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Data / Medical devices / Germany / Aesculap AG

Aesculap AG: FDA-registered device maker in TUTTLINGEN, DONAU Baden-Wurttemberg, Germany, 229 510(k) clearances and 1 PMA approval

Aesculap AG is registered with the FDA (registration 9610612) in TUTTLINGEN, DONAU Baden-Wurttemberg, Germany. It lists 411 device types. The FDA files 229 510(k) clearances and 1 PMA approval under its listings, the newest dated June 29, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Aesculap AG
FDA registration number
9610612
FEI number
3002806315
Address
Am Aesculap Platz, TUTTLINGEN, DONAU Baden-Wurttemberg, Germany, D-78532
Owner or operator
Aesculap AG (8010193)
Roles
Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
November 7, 1977
Registered through
2027
Brand names listed
ACCESSORIES AND MANUAL SAW, ADENOID CURETTE, ADENOTOME, AESCULAP, AFT SYSTEM TROCAR, AMPUTATION KNIFE, ANTRUM PERFORATOR, ANTRUM PUNCH and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufactureraccessdata.fda.gov
Accessories, CatheterKGZ1Manufactureraccessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Manufactureraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Manufactureraccessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY1Manufactureraccessdata.fda.gov
AdenotomeKBH1Manufactureraccessdata.fda.gov
AmniotomeHGE1Manufactureraccessdata.fda.gov
Anoscope And AccessoriesFER2Manufactureraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Manufactureraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Complaint file establishment, Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Manufactureraccessdata.fda.gov
Applicator, EntKCJ1Manufactureraccessdata.fda.gov
Applier, Aneurysm ClipHCI2Complaint file establishment, Manufactureraccessdata.fda.gov
Applier, CerclageHXN1Manufactureraccessdata.fda.gov
Applier, Hemostatic ClipHBT1Manufactureraccessdata.fda.gov
Applier, Staple, Surgical,GEF1Manufactureraccessdata.fda.gov
Applier, Surgical, ClipGDO1Manufactureraccessdata.fda.gov
ArthroscopeHRX2Complaint file establishmentaccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
Battery, Replacement, RechargeableMOQ1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufactureraccessdata.fda.gov
Blade, Saw, Surgical, CardiovascularDWH1Manufactureraccessdata.fda.gov
Blade, ScalpelGES1Manufactureraccessdata.fda.gov
Blower, Powder, EntKCL1Manufactureraccessdata.fda.gov
Bone MillLYS1Manufactureraccessdata.fda.gov
Bougie, UrologicalFAX1Manufactureraccessdata.fda.gov
Brace, DrillHXY1Manufactureraccessdata.fda.gov
BroachHTQ1Manufactureraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Manufactureraccessdata.fda.gov
Burnisher, OperativeEKJ1Manufactureraccessdata.fda.gov
Burr, OrthopedicHTT1Manufactureraccessdata.fda.gov
Cable, ElectrodeIKD2Manufactureraccessdata.fda.gov
CaliperKTZ1Manufactureraccessdata.fda.gov
Caliper, OphthalmicHOE1Manufactureraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufactureraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Manufactureraccessdata.fda.gov
Camera, Television, Surgical, With AudioFWC1Manufactureraccessdata.fda.gov
Cannula, InjectionFGY1Manufactureraccessdata.fda.gov
Cannula, Manipulator/Injector, UterineLKF2Manufactureraccessdata.fda.gov
Cannula, SinusKAM1Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufactureraccessdata.fda.gov
Cannula, VentricularHCD1Manufactureraccessdata.fda.gov
Carrier, Amalgam, OperativeEKI1Manufactureraccessdata.fda.gov
Carrier, LigatureGEJ1Manufactureraccessdata.fda.gov
Carver, Wax, DentalEIK1Manufactureraccessdata.fda.gov
Catheter, Eustachian, General & Plastic SurgeryGBY1Manufactureraccessdata.fda.gov
Catheter, IrrigationGBX1Manufactureraccessdata.fda.gov
Catheter, VentricularHCA2Complaint file establishment, Manufactureraccessdata.fda.gov
Cerclage, FixationJDQ2Manufactureraccessdata.fda.gov
Chamber, Acoustic (For Audiometric Testing)EWC1Manufactureraccessdata.fda.gov
Chisel (Osteotome)KDG1Manufactureraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Manufactureraccessdata.fda.gov
Chisel, Middle-EarJYE1Manufactureraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
ClampHXD1Manufactureraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Manufactureraccessdata.fda.gov
Clamp, PenileFHA1Manufactureraccessdata.fda.gov
Clamp, Rubber DamEEF1Manufactureraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufactureraccessdata.fda.gov
Clamp, UmbilicalHFW2Complaint file establishment, Manufactureraccessdata.fda.gov
Clamp, UterineHGC1Manufactureraccessdata.fda.gov
Clamp, VascularDXC2Manufactureraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Manufactureraccessdata.fda.gov
Clip, AneurysmHCH2Complaint file establishment, Manufactureraccessdata.fda.gov
Clip, ImplantableFZP2Manufactureraccessdata.fda.gov
Clip, Removable (Skin)FZQ1Manufactureraccessdata.fda.gov
Clip, ScalpHBO2Manufactureraccessdata.fda.gov
Clip, VascularDSS2Manufactureraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)KNF2Manufactureraccessdata.fda.gov
Condenser, Amalgam And Foil, OperativeEKG1Manufactureraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Manufactureraccessdata.fda.gov
CorkscrewHWI1Manufactureraccessdata.fda.gov
CountersinkHWW1Manufactureraccessdata.fda.gov
Cover, Burr HoleGXR2Complaint file establishment, Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Curette, AdenoidKBJ1Manufactureraccessdata.fda.gov
Curette, EarJYG1Manufactureraccessdata.fda.gov
Curette, NasalKAP1Manufactureraccessdata.fda.gov
Curette, Surgical, DentalEMK1Manufactureraccessdata.fda.gov
Curette, Surgical, General UseFZS1Contract manufacturer, Manufactureraccessdata.fda.gov
Curette, UterineHCY1Manufactureraccessdata.fda.gov
Cutter, SurgicalFZT1Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Manufactureraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Manufactureraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Manufactureraccessdata.fda.gov
DermatomeGFD1Manufactureraccessdata.fda.gov
Device, Digital Image Storage, RadiologicalLMB1Manufactureraccessdata.fda.gov
Device, Locking, For Intestinal ClampFFR1Manufactureraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Manufactureraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Manufactureraccessdata.fda.gov
Dilator, Esophageal (Metal Olive) Gastro-UrologyEZM2Manufactureraccessdata.fda.gov
Dilator, Esophageal, EntKCF1Manufactureraccessdata.fda.gov
Dilator, LachrymalHNW1Manufactureraccessdata.fda.gov
Dilator, NasalLWF1Manufactureraccessdata.fda.gov
Discriminator, Two-PointGWI1Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufactureraccessdata.fda.gov
Dissector, TonsilKBM1Manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Complaint file establishment, Manufactureraccessdata.fda.gov
Driver, Surgical, PinGFC1Manufactureraccessdata.fda.gov
Dura SubstituteGXQ2Complaint file establishment, Manufactureraccessdata.fda.gov
Dynamometer, NonpoweredHRW1Manufactureraccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
ElevatorHTE1Manufactureraccessdata.fda.gov
Elevator, EntKAD1Manufactureraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Manufactureraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Manufactureraccessdata.fda.gov
Endoscope, NeurologicalGWG2Manufactureraccessdata.fda.gov
Endoscopic Tissue Approximation DeviceOCW2Manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Manufactureraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Manufactureraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Manufactureraccessdata.fda.gov
Excavator, EarJYH1Manufactureraccessdata.fda.gov
Expander, Surgical, Skin GraftFZW1Manufactureraccessdata.fda.gov
Explorer, OperativeEKB1Manufactureraccessdata.fda.gov
ExtractorHWB1Manufactureraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Complaint file establishmentaccessdata.fda.gov
FileHTP1Manufactureraccessdata.fda.gov
File, Bone, SurgicalEMI1Manufactureraccessdata.fda.gov
File, PeriodonticEMR1Manufactureraccessdata.fda.gov
File, Surgical, General & Plastic SurgeryGEO1Manufactureraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Complaint file establishmentaccessdata.fda.gov
ForcepsHTD1Contract manufacturer, Manufactureraccessdata.fda.gov
Forceps, Articulation PaperEFK1Manufactureraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Manufactureraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Manufactureraccessdata.fda.gov
Forceps, EntKAE1Manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufactureraccessdata.fda.gov
Forceps, ObstetricalHDA2Complaint file establishment, Manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Manufactureraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Manufactureraccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Manufactureraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Manufactureraccessdata.fda.gov
Forceps, Wire HoldingHYA1Manufactureraccessdata.fda.gov
ForkHXE1Manufactureraccessdata.fda.gov
Fork, TuningGWX1Manufactureraccessdata.fda.gov
Frame, Rubber DamEJE1Manufactureraccessdata.fda.gov
Gag, MouthKBN1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Gauge, MeasuringJYJ1Manufactureraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Manufactureraccessdata.fda.gov
Goniometer, NonpoweredKQW1Manufactureraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Manufactureraccessdata.fda.gov
Guard, InstrumentLXZ1Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Contract manufacturer, Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Handpiece (Brace), DrillHBD1Manufactureraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Manufactureraccessdata.fda.gov
Headrest, NeurosurgicalHBM1Manufactureraccessdata.fda.gov
HemostatHRQ1Manufactureraccessdata.fda.gov
Hemostat, SurgicalEMD1Manufactureraccessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOQG2Manufactureraccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOQI2Manufactureraccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, CementedOQH2Manufactureraccessdata.fda.gov
Hoe, PeriodonticEMQ1Manufactureraccessdata.fda.gov
Holder, Camera, SurgicalFXR1Manufactureraccessdata.fda.gov
Holder, Ear SpeculumJYK1Manufactureraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Manufactureraccessdata.fda.gov
Holder, Speculum, EntKAG1Manufactureraccessdata.fda.gov
Hook, BoneKIK1Contract manufacturer, Manufactureraccessdata.fda.gov
Hook, Microsurgical EarJYL1Complaint file establishment, Manufactureraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufactureraccessdata.fda.gov
Hook, TrachealKCH1Manufactureraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Manufactureraccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Manufactureraccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufactureraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Manufactureraccessdata.fda.gov
Instrument, Cast Removal, Ac-PoweredLGH1Manufactureraccessdata.fda.gov
Instrument, Clip RemovalHBQ1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Instrument, Contouring, Matrix, OperativeEKF1Complaint file establishment, Manufactureraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Manufactureraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Manufactureraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Manufactureraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Manufactureraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Manufactureraccessdata.fda.gov
Instrument, Manual, Specialized Obstetric-GynecologicKNA2Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Manufactureraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Manufactureraccessdata.fda.gov
Instrument, Shunt System ImplantationGYK1Manufactureraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Manufactureraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUManufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Contract manufacturer, Manufactureraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Exporter to the USaccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Manufactureraccessdata.fda.gov
Irrigator, SinusKAR1Manufactureraccessdata.fda.gov
Knife, AmputationGDN1Manufactureraccessdata.fda.gov
Knife, EarJYO1Manufactureraccessdata.fda.gov
Knife, EntKTG1Manufactureraccessdata.fda.gov
Knife, LaryngealJZY1Manufactureraccessdata.fda.gov
Knife, Margin Finishing, OperativeEJZ1Manufactureraccessdata.fda.gov
Knife, MyringotomyJYP1Manufactureraccessdata.fda.gov
Knife, NasalKAS1Manufactureraccessdata.fda.gov
Knife, OrthopedicHTS1Manufactureraccessdata.fda.gov
Knife, PeriodonticEMO1Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
Knife, TonsilKBQ1Manufactureraccessdata.fda.gov
Label Or Tag, SterileLYV1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Exporter to the USaccessdata.fda.gov
Laryngoscope, RigidCCW1Manufactureraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Manufactureraccessdata.fda.gov
Light, Headband, SurgicalFSR2Manufactureraccessdata.fda.gov
Light, Surgical, Floor StandingFSS2Complaint file establishment, Manufactureraccessdata.fda.gov
Loop, WireJYQ1Manufactureraccessdata.fda.gov
Loupe, Binocular, Low PowerHJH1Manufactureraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Manufactureraccessdata.fda.gov
MalletHXL1Contract manufacturer, Manufactureraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Manufactureraccessdata.fda.gov
Marker, PeriodonticEMP1Manufactureraccessdata.fda.gov
Marker, SkinFZZ1Manufactureraccessdata.fda.gov
Microscope, Surgical, General & Plastic SurgeryFSO1Complaint file establishment, Manufactureraccessdata.fda.gov
Mirror, EntKAI1Manufactureraccessdata.fda.gov
Mirror, General & Plastic SurgeryFTX1Manufactureraccessdata.fda.gov
Mirror, Headband, OphthalmicHKF1Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Manufactureraccessdata.fda.gov
Motor, Drill, ElectricHBC2Complaint file establishment, Manufactureraccessdata.fda.gov
Motor, Drill, PneumaticHBB2Manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Pneumatic PoweredGET1Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Manufactureraccessdata.fda.gov
Needle, DentalDZM1Complaint file establishment, Manufactureraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Manufactureraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Manufactureraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Manufactureraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Manufactureraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Complaint file establishment, Manufactureraccessdata.fda.gov
Nipper, MalleusJYR1Manufactureraccessdata.fda.gov
Obturator, For EndoscopeFEC2Manufactureraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufacturer, Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishmentaccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, MetalNQW2Complaint file establishmentaccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Manufactureraccessdata.fda.gov
OsteotomeHWM1Contract manufacturer, Manufactureraccessdata.fda.gov
Osteotome, ManualGFI1Manufactureraccessdata.fda.gov
OtoscopeERA1Manufactureraccessdata.fda.gov
Packer, UterineHDM1Manufactureraccessdata.fda.gov
PasserHWQ1Manufactureraccessdata.fda.gov
Pelvimeter, ExternalHER1Manufactureraccessdata.fda.gov
PercussorGWZ1Manufactureraccessdata.fda.gov
Perforator, AntrumKAT1Manufactureraccessdata.fda.gov
Pick, Microsurgical EarJYT1Manufactureraccessdata.fda.gov
PinwheelGWY1Manufactureraccessdata.fda.gov
Plate, BoneJEY2Manufactureraccessdata.fda.gov
Plate, Cranioplasty, Preformed, Non-AlterableGXN2Complaint file establishment, Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Complaint file establishmentaccessdata.fda.gov
Plier, OrthodonticJEX1Manufactureraccessdata.fda.gov
Pliers, OperativeEJY1Manufactureraccessdata.fda.gov
Pliers, SurgicalHTC1Manufactureraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Manufactureraccessdata.fda.gov
Pneumoperitoneum NeedleFHO2Exporter to the USaccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Manufactureraccessdata.fda.gov
Probe, EntKAK1Manufactureraccessdata.fda.gov
Probe, PeriodonticEIX1Manufactureraccessdata.fda.gov
Probe, Rectal, Non-PoweredEXX1Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedLWJ2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateMEH2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Intervertebral DiscMJO3Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY2Complaint file establishmentaccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Complaint file establishment, Manufactureraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Manufactureraccessdata.fda.gov
Punch, AntrumKAW1Manufactureraccessdata.fda.gov
Punch, EntKTF1Manufactureraccessdata.fda.gov
Punch, Femoral NeckHWP1Manufactureraccessdata.fda.gov
Punch, NasalKAY1Manufactureraccessdata.fda.gov
Punch, SkullGXJ1Manufactureraccessdata.fda.gov
Punch, SurgicalLRY1Manufactureraccessdata.fda.gov
Punch, TonsilKBT1Manufactureraccessdata.fda.gov
Pusher, SocketHXO1Manufactureraccessdata.fda.gov
RaspHTR1Contract manufacturer, Manufactureraccessdata.fda.gov
Rasp, EarJYY1Manufactureraccessdata.fda.gov
Rasp, NasalKBA1Manufactureraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Contract manufacturer, Manufactureraccessdata.fda.gov
Razor, SurgicalLWK1Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Manufactureraccessdata.fda.gov
Regulator, VacuumKDP2Manufactureraccessdata.fda.gov
Remover, CrownEIS1Manufactureraccessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-TypeHHF1Manufactureraccessdata.fda.gov
Retainer, MatrixJEP1Manufactureraccessdata.fda.gov
Retention Device, SutureKGS1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Manufactureraccessdata.fda.gov
Retractor, EntKAL1Manufactureraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Manufactureraccessdata.fda.gov
Retractor, OphthalmicHNI1Manufactureraccessdata.fda.gov
Retractor, Self-RetainingFFO1Manufactureraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Complaint file establishment, Manufactureraccessdata.fda.gov
Retractor, VaginalHDL1Manufactureraccessdata.fda.gov
Ring, LaparotomyFHI1Manufactureraccessdata.fda.gov
RongeurHTX1Contract manufacturer, Manufactureraccessdata.fda.gov
Rongeur, ManualHAE2Manufactureraccessdata.fda.gov
Rongeur, NasalKBB1Manufactureraccessdata.fda.gov
Rongeur, PoweredHAD2Manufactureraccessdata.fda.gov
SawHSO1Manufactureraccessdata.fda.gov
Saw, Electrically PoweredDWI1Manufactureraccessdata.fda.gov
Saw, Manual And AccessoriesGDR1Manufactureraccessdata.fda.gov
Saw, NasalKBC1Manufactureraccessdata.fda.gov
Saw, Pneumatically PoweredKFK1Manufactureraccessdata.fda.gov
Saw, Powered, And AccessoriesHAB1Manufactureraccessdata.fda.gov
Scaler, PeriodonticEMN1Manufactureraccessdata.fda.gov
Scalpel, One-PieceGDX1Manufactureraccessdata.fda.gov
Scissors, Collar And CrownEIR1Manufactureraccessdata.fda.gov
Scissors, EpisiotomyHDK1Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Scissors, NasalKBD1Manufactureraccessdata.fda.gov
Scissors, OphthalmicHNF1Manufactureraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufactureraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Manufactureraccessdata.fda.gov
Scissors, UmbilicalHDJ1Manufactureraccessdata.fda.gov
Scissors, Wire Cutting, Ent, SterileJYA1Manufactureraccessdata.fda.gov
ScoopFHL1Manufactureraccessdata.fda.gov
Scrapper, Skin SpecimenLXK1Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Complaint file establishment, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Shunt, Central Nervous System And ComponentsJXG2Complaint file establishmentaccessdata.fda.gov
Snare, EarJZD1Manufactureraccessdata.fda.gov
Snare, NasalKBE1Manufactureraccessdata.fda.gov
Snare, TonsilKBZ1Manufactureraccessdata.fda.gov
Sound, Urethral, Metal Or PlasticFBX1Manufactureraccessdata.fda.gov
Sound, UterineHHM1Manufactureraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Manufactureraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Manufactureraccessdata.fda.gov
Spectacle, MagnifyingHOI1Manufactureraccessdata.fda.gov
Specula, OphthalmicHNC1Manufactureraccessdata.fda.gov
Speculum, EntEPY1Manufactureraccessdata.fda.gov
Speculum, RectalFFQ1Manufactureraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Manufactureraccessdata.fda.gov
SphyncteroscopeFDR2Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Complaint file establishment, Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Complaint file establishmentaccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Manufactureraccessdata.fda.gov
Stabilizer, HeartMWS1Manufactureraccessdata.fda.gov
Starter, Bone ScrewHWD1Manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Sterilizer, SteamFLE2Manufactureraccessdata.fda.gov
Stethoscope, FetalHGN1Manufactureraccessdata.fda.gov
Stethoscope, ManualLDE1Manufactureraccessdata.fda.gov
Stripper, SurgicalHRT1Manufactureraccessdata.fda.gov
Stripper, Vein, DisposableGAJ1Manufactureraccessdata.fda.gov
Stripper, Vein, ReusableGAI1Manufactureraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Complaint file establishment, Manufactureraccessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)KOA1Manufactureraccessdata.fda.gov
Syringe, Balloon InflationMAV2Manufactureraccessdata.fda.gov
Syringe, EntKCP1Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufactureraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Manufactureraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Manufactureraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Complaint file establishment, Manufactureraccessdata.fda.gov
Table And Attachments, Operating-RoomBWN1Manufactureraccessdata.fda.gov
Table, Operating-Room, Ac-PoweredFQO1Manufactureraccessdata.fda.gov
Table, Operating-Room, ManualFSE1Manufactureraccessdata.fda.gov
TampHXG1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufactureraccessdata.fda.gov
TemplateHWT1Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Manufactureraccessdata.fda.gov
Tissue Adhesive For The Topical Approximation Of SkinMPN2Manufactureraccessdata.fda.gov
TonsillectomeKCA1Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Manufactureraccessdata.fda.gov
Tray, Surgical, EntMMO1Complaint file establishment, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
TrephineHWK1Manufactureraccessdata.fda.gov
Trocar, EntKTE1Manufactureraccessdata.fda.gov
Trocar, Gastro-UrologyFBQ2Manufactureraccessdata.fda.gov

11 more device types in the FDA listing

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 229.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 29, 2023K223596SQ.line KERRISONHAESubstantially EquivalentAesculap, Inc.accessdata.fda.gov
July 1, 2022K213871Ennovate Cervical Spinal and Occiput SystemNKGSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
December 13, 2021K211572Aesculap Slim Clip ApplierHCISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
August 24, 2021K203739ELAN 4 Electro Motor SystemHBESubstantially EquivalentAesculap, Inc.accessdata.fda.gov
July 19, 2021K210963ENNOVATE Spinal SystemNKBSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
January 21, 2021K202391DIR 800IZISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
December 18, 2020K203461Aesculap Caiman 12 Seal and Cut Technology SystemGEISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
October 30, 2020K202938Aesculap Caiman 5 Seal and Cut Technology SystemGEISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
March 27, 2020K192056JJ Series Container SystemKCTSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
March 17, 2020K193582SterilContainer S2 SystemKCTSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
July 5, 2019K182414Aesculap® SterilContainer(TM) S2 SystemKCTSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
March 12, 2019K183180Caiman 5 MarylandGEISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
January 19, 2019K182527ELAN 4 ToolsHBESubstantially EquivalentAesculap, Inc.accessdata.fda.gov
November 9, 2018K172907ELAN 4 Air Motor SystemHBBSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
October 17, 2018K172709ELAN 4 Electro Motor System ToolsHBESubstantially EquivalentAesculap, Inc.accessdata.fda.gov
April 26, 2018K180433ENNOVATE®NKBSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
March 28, 2018K172235CoreHip® SystemLZOSubstantially EquivalentAesculap Implants Systems, LLCaccessdata.fda.gov
February 20, 2018K170683Aesculap Video Assisted Thoracic Surgery (VATS) INstrumentsGCJSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
November 20, 2017K172032Modulift Vertebral Body Replacement (VBR) SystemPLRSubstantially EquivalentAesculap Implants Systems, Inc.accessdata.fda.gov
December 14, 2016K162134ENNOVATE Spinal SystemNKBSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
July 22, 2016K152960ELAN 4 Motor SystemHBCSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
May 26, 2016K160393AdTecGCJSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
May 25, 2016K153629ArcadiusXP C Spinal SystemOVESubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
May 16, 2016K153396Aesculap OrthoPilot Next GenerationOLOSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
October 9, 2015K151242SterilContainer SKCTSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
August 18, 2015K143729SterilContainer SKCTSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
August 13, 2015K151056Aesculap T-Space PEEK and XP Spinal SystemMAXSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
July 21, 2015K151858Caiman Seal and Cut TechnologyGEISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
July 20, 2015K151696Caiman Seal and Cut TechnologyGEISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
July 8, 2015K142970SterilContainer S SystemKCTSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
April 2, 2015K141687AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEMJXGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
March 25, 2015K143443VEGA Knee System, Columbus Total Knee SystemJWHSubstantially EquivalentAesculap Implants Systems, LLCaccessdata.fda.gov
February 24, 2015K141694AESCULAP ORTHOPILOT NEXT GENERATIONOLOSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
February 9, 2015K150062Excia Total Hip SystemLZOSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
December 19, 2014K142707AIS Odontoid Fracture Fixation SystemHWCSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
November 21, 2014K143106VEGA Knee SystemJWHSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
October 29, 2014K142150AIS MODULIFT VBR SYSTEMMQPSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
July 21, 2014K140915EXCIA TOTAL HIP SYSTEMLZOSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
April 28, 2014K140839CAIMAN SEAL AND CUT TECHNOLOGYGEISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
April 17, 2014K133802AIS MODULIFT VBR SYSTEMMQPSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
March 25, 2014K140452VEGA KNEE SYSTEMJWHSubstantially EquivalentAesculap Implant Systemsaccessdata.fda.gov
January 24, 2014K131500YASARGIL ANEURYSM CLIPS AND CLIP APPLIERSHCHSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
January 22, 2014K132421AESCULAP PEEK XP SPINAL IMPLANT SYSTEMMAXSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
October 30, 2013K122783PLASMAFIT ACETABULAR CUP AND VITELENE INSERTOQGSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
October 17, 2013K131167UNIVATIONHRYSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
August 13, 2013K130887S4C NAVIGATION INSTRUMENTSOLOSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
June 4, 2013K122791LYOPLANT ONLAYGXQSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
April 15, 2013K123909AESCULAP CESPACE XPODPSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
April 11, 2013K130291S4 SPINAL SYSTEMNKBSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
March 22, 2013K130596CAIMAN SEAL AND CUT TECHNOLOGYGEISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
March 12, 2013K123939S4 SPINAL SYSTEMNKBSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
December 17, 2012K120955COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEMJWHSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
December 12, 2012K123352S4 SPINAL SYSTEMNKBSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
October 26, 2012K122985COLUMBUS REVISION KNEE SYSTEMJWHSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
September 11, 2012K121801QUINTEX CERVICAL PLATING SYSTEMKWQSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
August 30, 2012K122353CRAINFIX 2 TITANIUM CLAMP SYSTEMGXNSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
July 27, 2012K121879VEGA KNEE SYSTEMJWHSubstantially EquivalentAesculap Implant Systemsaccessdata.fda.gov
May 24, 2012K120559AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEMJXGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
May 4, 2012K112671STERILCONTAINER SYSTEMKCTSubstantially EquivalentAesculap, Ltd.accessdata.fda.gov
March 19, 2012K112682METHA HIP SYSTEMLZOSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
November 21, 2011K112551S4 SPINAL SYSTEMNKBSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
October 27, 2011K110206AESCULAP- MEITHKE SHUNT SYSTEMJXGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
August 19, 2011K111441UNIMAX VERESS NEEDLEHIFSubstantially EquivalentUnimax Medical Systems, Inc.accessdata.fda.gov
August 4, 2011K111122AESCULAP SIBD XP SPINAL SYSTEMOVDSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
June 28, 2011K110695BIPOLAR HF DEVICEGEISubstantially EquivalentAesculap, Inc.accessdata.fda.gov
June 15, 2011K110864BIOSPINE VBR SYSTEMMQPSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
December 21, 2010K102057TARGON FN SYSTEMKTTSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
December 20, 2010K101815ENDURO KNEE SYSTEMKROSubstantially EquivalentAesculap Implant Systemsaccessdata.fda.gov
December 2, 2010K103284LAMINOPLASY PLATING SYSTEMNQWSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
November 24, 2010K102505HTO PLATING SYSTEMHRSSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
November 9, 2010K103003AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEMJXGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
September 2, 2010K100243QUINTEX CERVICAL PLATING SYSTEMKWQSubstantially EquivalentAesculap Implant Systems, LLCaccessdata.fda.gov
August 12, 2010K091692AESCULAP PEEK CRANIOFIXGXRSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
August 11, 2010K101937HYBRID TROCAR SYSTEMGCJSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
August 6, 2010K102081ENDOSCOPIC CLIP SYSTEMFZPSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
July 30, 2010K101281VEGA KNEE SYSTEMJWHSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
July 27, 2010K093493AESCULAP STERILCONTAINER SFRGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
July 23, 2010K100147S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEMNKBSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
July 20, 2010K100802AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEMOVDSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
June 9, 2010K100623AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEMNKBSubstantially EquivalentAesculap Implant Systemsaccessdata.fda.gov
May 11, 2010K093649AESCULAP STERILCONTAINER SFRGSubstantially EquivalentAesculapaccessdata.fda.gov
March 4, 2010K083186AESCULAP HYDROLIFT VBR SYSTEMMQPSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
January 21, 2010K093075ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENTGEISubstantially EquivalentAragon Surgical, Inc.accessdata.fda.gov
September 22, 2009K092143EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEMMEHSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
June 4, 2009K083772COLUMBUS REVISION KNEE SYSTEMJWHSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
May 12, 2009K090354LAMINOPLASTY PLATING SYSTEMNQWSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
April 24, 2009K090299BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADSLZOSubstantially EquivalentAesculap Implant Systemsaccessdata.fda.gov
April 20, 2009K090657MODIFICATION TO: S4 SPINAL SYSTEMNKBSubstantially EquivalentAesculap Implant Systemsaccessdata.fda.gov
March 4, 2009K083311AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEMODPSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
January 15, 2009K083495MODIFICATION TO: METHA HIP SYSTEMLZOSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
November 20, 2008K082991BIOLOX DELTA CERAMIC FEMORAL HEADLZOSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
September 22, 2008K081293UNIVATION UNICONDYLAR KNEE SYSTEMHRYSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
September 4, 2008K080992AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEMHRSSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
August 7, 2008K081973METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEMLZOSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
June 2, 2008K071916METHA HIP SYSTEMMEHSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
May 23, 2008K080547ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106HAWSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
May 9, 2008K080584METHA SHORT STEM HIP SYSTEMMEHSubstantially EquivalentAesculap Implant System, Inc.accessdata.fda.gov
May 5, 2008K081031ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINEFZPSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
May 1, 2008K071983AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACEMAXSubstantially EquivalentAesculap Implant Systems, Inc.accessdata.fda.gov
April 28, 2008K073168AESCULAP PRIMELINE CONTAINER LTD.KCTSubstantially EquivalentAesculap, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 16, 2007P050013HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVEMPN0February 16, 2007accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 18, 202597507Class IIOngoingAESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."accessdata.fda.gov

Compare with other makers

Updated October 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.