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Data / Medical devices / Mexico / Industrias Apson S.A de C.V

Industrias Apson S.A de C.V: FDA-registered device maker in AGUA PRIETA Sonora, Mexico, 8 510(k) clearances

Industrias Apson S.A de C.V is registered with the FDA (registration 8030607) in AGUA PRIETA Sonora, Mexico. It lists 450 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 20, 1997. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Industrias Apson S.A de C.V
FDA registration number
8030607
FEI number
3006509795
Address
CALLE 15, # 780 Avenida 6-10, AGUA PRIETA Sonora, Mexico, 84200
Owner or operator
Aspen Surgical Products (10061390)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 14, 2019
Registered through
2027
Brand names listed
Bard-Parker Scalpel Blade Remover, Beach Chair Head and Chin Straps, Berkette Beach Chair Limb Positioner, Bethesda Face Mask, BlueMed, Bovie Medical, CS Medical, Carson Perineal Post Pad and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Contract manufactureraccessdata.fda.gov
Accessories, CatheterKGZ1Contract manufactureraccessdata.fda.gov
Accessories, Cleaning Brushes, For EndoscopeMNL1Contract manufactureraccessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Contract manufactureraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Manufactureraccessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY1Contract manufactureraccessdata.fda.gov
Adaptor, CatheterGCE1Contract manufactureraccessdata.fda.gov
Adaptor, Holder, SyringeIQG1Contract manufactureraccessdata.fda.gov
AdenotomeKBH1Contract manufactureraccessdata.fda.gov
Aid, TransferIKX1Contract manufactureraccessdata.fda.gov
Anti Fog Solution And Accessories, EndoscopyOCT2Contract manufactureraccessdata.fda.gov
Anvil, Skull PlateGXM1Contract manufactureraccessdata.fda.gov
Apparatus, ElectrosurgicalHAM2Contract manufactureraccessdata.fda.gov
Apparatus, Exhaust, SurgicalFYD2Contract manufactureraccessdata.fda.gov
Apparatus, Suturing, Stomach And IntestinalFHM1Contract manufactureraccessdata.fda.gov
Apparatus, Traction, Non-PoweredHST1Contract manufactureraccessdata.fda.gov
Appliance, Facial Fracture, ExternalFYI1Contract manufactureraccessdata.fda.gov
Applicator, EntKCJ1Contract manufactureraccessdata.fda.gov
Applier, Hemostatic ClipHBT1Contract manufactureraccessdata.fda.gov
ArthroscopeHRX2Contract manufactureraccessdata.fda.gov
AwlHWJ1Contract manufactureraccessdata.fda.gov
Bag, IceKYR1Manufactureraccessdata.fda.gov
Balloon, EpistaxisEMX1Contract manufactureraccessdata.fda.gov
Bandage, CastITG1Contract manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Contract manufactureraccessdata.fda.gov
Basin, EmesisFNY1Contract manufactureraccessdata.fda.gov
Bath, Incubators/Water, AllJTQ1Contract manufactureraccessdata.fda.gov
Battery, Replacement, RechargeableMOQ1Contract manufactureraccessdata.fda.gov
Bed, ManualFNJ1Contract manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Contract manufactureraccessdata.fda.gov
BedpanFOB1Contract manufactureraccessdata.fda.gov
BenderHXW1Contract manufactureraccessdata.fda.gov
Binder, ElasticKMO1Contract manufactureraccessdata.fda.gov
Binder, PerinealFQK1Contract manufactureraccessdata.fda.gov
Bistoury, TrachealKCC1Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Contract manufactureraccessdata.fda.gov
Block, Cutting, Ent, SterileJXS1Contract manufactureraccessdata.fda.gov
Blower, Powder, EntKCL1Contract manufactureraccessdata.fda.gov
Bougie, Esophageal, EntKCD1Contract manufactureraccessdata.fda.gov
Bougie, EustachianKBI1Contract manufactureraccessdata.fda.gov
Bougie, UrologicalFAX1Contract manufactureraccessdata.fda.gov
Brace, DrillHXY1Contract manufactureraccessdata.fda.gov
BroachHTQ1Contract manufactureraccessdata.fda.gov
Broach, EndodonticEKW1Contract manufactureraccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Contract manufactureraccessdata.fda.gov
Brush, Dermabrasion, PoweredGFE1Contract manufactureraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Contract manufactureraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Contract manufactureraccessdata.fda.gov
Burnisher, OperativeEKJ1Contract manufactureraccessdata.fda.gov
Burr, Corneal, Battery-PoweredHOG1Contract manufactureraccessdata.fda.gov
Burr, Corneal, ManualHOF1Contract manufactureraccessdata.fda.gov
Burr, OrthopedicHTT1Contract manufactureraccessdata.fda.gov
Camera, Cine, Endoscopic, With AudioFTS1Contract manufactureraccessdata.fda.gov
Camera, Still, EndoscopicFXM1Contract manufactureraccessdata.fda.gov
Camera, Television, Surgical, With AudioFWC1Contract manufactureraccessdata.fda.gov
Cannula, EarJYC1Contract manufactureraccessdata.fda.gov
Cannula, InjectionFGY1Contract manufactureraccessdata.fda.gov
Cannula, SinusKAM1Contract manufactureraccessdata.fda.gov
Cannula, VentricularHCD1Contract manufactureraccessdata.fda.gov
Cannulae, BronchialKCE1Contract manufactureraccessdata.fda.gov
Cap, SurgicalFYF1Manufactureraccessdata.fda.gov
Carrier, LigatureGEJ1Contract manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Contract manufactureraccessdata.fda.gov
Catheter, Balloon TypeGBA1Contract manufactureraccessdata.fda.gov
Catheter, CholangiographyGBZ1Contract manufactureraccessdata.fda.gov
Catheter, Eustachian, General & Plastic SurgeryGBY1Contract manufactureraccessdata.fda.gov
Catheter, IrrigationGBX1Contract manufactureraccessdata.fda.gov
Catheter, Multiple LumenGBP1Contract manufactureraccessdata.fda.gov
Catheter, PeritonealGBW1Contract manufactureraccessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Contract manufactureraccessdata.fda.gov
Chair And Table, MedicalKMN1Contract manufactureraccessdata.fda.gov
Chair, Blood DonorFML1Contract manufactureraccessdata.fda.gov
Chair, Examination And TreatmentFRK1Contract manufactureraccessdata.fda.gov
Chair, Surgical, Ac-PoweredGBB1Contract manufactureraccessdata.fda.gov
Chair, Surgical, Non-ElectricalFZK1Contract manufactureraccessdata.fda.gov
Chair, With CastersINM1Contract manufactureraccessdata.fda.gov
Chisel (Osteotome)KDG1Contract manufactureraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Contract manufactureraccessdata.fda.gov
Chisel, MastoidJYD1Contract manufactureraccessdata.fda.gov
Chisel, Middle-EarJYE1Contract manufactureraccessdata.fda.gov
Chisel, NasalKAN1Contract manufactureraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Contract manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Contract manufactureraccessdata.fda.gov
ClampHXD1Contract manufactureraccessdata.fda.gov
Clamp, CannulaFKC1Contract manufactureraccessdata.fda.gov
Clamp, LineFKK1Contract manufactureraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Contract manufactureraccessdata.fda.gov
Clamp, Ossicle HoldingJYF1Contract manufactureraccessdata.fda.gov
Clamp, PenileFHA1Contract manufactureraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Contract manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Contract manufactureraccessdata.fda.gov
Clip, AneurysmHCH2Contract manufactureraccessdata.fda.gov
Clip, ImplantableFZP2Contract manufactureraccessdata.fda.gov
Clip, Removable (Skin)FZQ1Contract manufactureraccessdata.fda.gov
Clip, ScalpHBO2Contract manufactureraccessdata.fda.gov
Coagulator, Culdoscopic (And Accessories)HFI2Contract manufactureraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)HIN2Contract manufactureraccessdata.fda.gov
Collagen Corneal ShieldMOE1Contract manufactureraccessdata.fda.gov
Component, Traction, Non-InvasiveKQZ1Contract manufactureraccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Contract manufactureraccessdata.fda.gov
Contractor, SurgicalFZR1Contract manufactureraccessdata.fda.gov
CorkscrewHWI1Contract manufactureraccessdata.fda.gov
CountersinkHWW1Contract manufactureraccessdata.fda.gov
Cover, LimbIPM1Contract manufactureraccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Contract manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Manufactureraccessdata.fda.gov
Crimper, PinHXQ1Contract manufactureraccessdata.fda.gov
Crimper, Wire, Ent, SterileJXT1Contract manufactureraccessdata.fda.gov
Culdoscope (And Accessories)HEW2Contract manufactureraccessdata.fda.gov
CuretteHTF1Contract manufactureraccessdata.fda.gov
Curette, AdenoidKBJ1Contract manufactureraccessdata.fda.gov
Curette, EarJYG1Contract manufactureraccessdata.fda.gov
Curette, EndodonticEKT1Contract manufactureraccessdata.fda.gov
Curette, EthmoidKAO1Contract manufactureraccessdata.fda.gov
Curette, NasalKAP1Contract manufactureraccessdata.fda.gov
Curette, PeriodonticEMS1Contract manufactureraccessdata.fda.gov
Curette, Surgical, DentalEMK1Contract manufactureraccessdata.fda.gov
Curette, Surgical, General UseFZS1Contract manufactureraccessdata.fda.gov
Curette, UterineHCY1Contract manufactureraccessdata.fda.gov
Cushion, FlotationKIC1Contract manufactureraccessdata.fda.gov
Cutter, SurgicalFZT1Contract manufactureraccessdata.fda.gov
Cutter, WireHXZ1Contract manufactureraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Contract manufactureraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Contract manufactureraccessdata.fda.gov
DermatomeGFD1Contract manufactureraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Contract manufactureraccessdata.fda.gov
Device, Locking, For Intestinal ClampFFR1Contract manufactureraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Contract manufactureraccessdata.fda.gov
Device, Percutaneous, BiopsyMJG1Contract manufactureraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Contract manufactureraccessdata.fda.gov
Die, Wire Bending, Ent, SterileJXW1Complaint file establishmentaccessdata.fda.gov
Dilator, CatheterGCC1Contract manufactureraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Contract manufactureraccessdata.fda.gov
Dilator, Esophageal, EntKCF1Contract manufactureraccessdata.fda.gov
Dilator, RectalFFP1Contract manufactureraccessdata.fda.gov
Dilator, TrachealKCG1Contract manufactureraccessdata.fda.gov
Discriminator, Two-PointGWI1Contract manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Contract manufactureraccessdata.fda.gov
Dissector, TonsilKBM1Contract manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Contract manufacturer, Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)HBG2Contract manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Contract manufactureraccessdata.fda.gov
Driver, ProsthesisHWR1Contract manufactureraccessdata.fda.gov
Driver, Surgical, PinGFC1Contract manufactureraccessdata.fda.gov
Dynamometer, NonpoweredHRW1Contract manufactureraccessdata.fda.gov
Ear WickKCN1Contract manufactureraccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Contract manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
ElevatorHTE1Contract manufactureraccessdata.fda.gov
Elevator, EntKAD1Contract manufactureraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Contract manufactureraccessdata.fda.gov
Erythrosin BKJR1Contract manufactureraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Contract manufactureraccessdata.fda.gov
Excavator, EarJYH1Contract manufactureraccessdata.fda.gov
Expander, Surgical, Skin GraftFZW1Contract manufactureraccessdata.fda.gov
ExtractorHWB1Contract manufactureraccessdata.fda.gov
Eye, Artificial, Non-CustomHQH1Contract manufactureraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Contract manufactureraccessdata.fda.gov
FileHTP1Contract manufactureraccessdata.fda.gov
File, Bone, SurgicalEMI1Contract manufactureraccessdata.fda.gov
File, PeriodonticEMR1Contract manufactureraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Contract manufactureraccessdata.fda.gov
Film, RadiographicIWZ1Contract manufactureraccessdata.fda.gov
Floss, DentalJES1Contract manufactureraccessdata.fda.gov
ForcepsHTD1Contract manufactureraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Contract manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Contract manufactureraccessdata.fda.gov
Forceps, DisconnectFJR1Contract manufactureraccessdata.fda.gov
Forceps, EntKAE1Contract manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Contract manufactureraccessdata.fda.gov
Forceps, ObstetricalHDA2Contract manufactureraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Contract manufactureraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Contract manufactureraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Contract manufactureraccessdata.fda.gov
Forceps, Wire Closure, Ent, SterileJXX1Contract manufactureraccessdata.fda.gov
Forceps, Wire HoldingHYA1Contract manufactureraccessdata.fda.gov
ForkHXE1Contract manufactureraccessdata.fda.gov
Fork, TuningGWX1Contract manufactureraccessdata.fda.gov
Gag, MouthKBN1Contract manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Contract manufactureraccessdata.fda.gov
Gauge, MastoidJYI1Contract manufactureraccessdata.fda.gov
Gauge, MeasuringJYJ1Contract manufactureraccessdata.fda.gov
Goniometer, NonpoweredKQW1Contract manufactureraccessdata.fda.gov
Gouge, Nasal, EntKAQ1Contract manufactureraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Contract manufactureraccessdata.fda.gov
Gown, ExaminationFME1Manufactureraccessdata.fda.gov
Gown, SurgicalFYA2Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufactureraccessdata.fda.gov
Gutta-PerchaEKM1Contract manufactureraccessdata.fda.gov
Halter, Head, TractionHSS1Contract manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Contract manufactureraccessdata.fda.gov
Hand, External Limb Component, MechanicalIRA1Contract manufactureraccessdata.fda.gov
Handpiece (Brace), DrillHBD1Contract manufactureraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Contract manufactureraccessdata.fda.gov
Headrest, NeurosurgicalHBM1Contract manufactureraccessdata.fda.gov
Helmet, SurgicalFXZ1Contract manufactureraccessdata.fda.gov
Hemostat, SurgicalEMD1Contract manufactureraccessdata.fda.gov
Hoe, PeriodonticEMQ1Contract manufactureraccessdata.fda.gov
Holder, Camera, SurgicalFXR1Contract manufactureraccessdata.fda.gov
Holder, Ear SpeculumJYK1Contract manufactureraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Contract manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Contract manufactureraccessdata.fda.gov
Holder, Speculum, EntKAG1Contract manufactureraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Contract manufactureraccessdata.fda.gov
Hook, BoneKIK1Contract manufactureraccessdata.fda.gov
Hook, Fibroid, GynecologicalHDE1Contract manufactureraccessdata.fda.gov
Hook, Gastro-UrologyFHB1Contract manufactureraccessdata.fda.gov
Hook, Microsurgical EarJYL1Contract manufactureraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Contract manufactureraccessdata.fda.gov
Hook, Tonsil SuturingKBP1Contract manufactureraccessdata.fda.gov
Hook, TrachealKCH1Contract manufactureraccessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)KFZ1Contract manufactureraccessdata.fda.gov
Illuminator, Non-RemoteFTF2Contract manufactureraccessdata.fda.gov
ImpactorHWA1Contract manufactureraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Contract manufactureraccessdata.fda.gov
Inserter, Myringotomy TubeJYM1Contract manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Contract manufactureraccessdata.fda.gov
Instrument, Catheter, PunchFEX1Contract manufactureraccessdata.fda.gov
Instrument, Clip RemovalHBQ1Contract manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Contract manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Contract manufactureraccessdata.fda.gov
Instrument, Hand, Calculus RemovalELA1Contract manufactureraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Contract manufactureraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Contract manufactureraccessdata.fda.gov
Instrument, Shunt System ImplantationGYK1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentHSZ1Contract manufactureraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Contract manufactureraccessdata.fda.gov
Irrigator, SinusKAR1Contract manufactureraccessdata.fda.gov
Jig, Piston Cutting, Ent, SterileJXY1Contract manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract manufactureraccessdata.fda.gov
Knife, EarJYO1Contract manufactureraccessdata.fda.gov
Knife, LaryngealJZY1Contract manufactureraccessdata.fda.gov
Knife, MyringotomyJYP1Contract manufactureraccessdata.fda.gov
Knife, NasalKAS1Contract manufactureraccessdata.fda.gov
Knife, OrthopedicHTS1Contract manufactureraccessdata.fda.gov
Knife, PeriodonticEMO1Contract manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Contract manufactureraccessdata.fda.gov
Knife, TonsilKBQ1Contract manufactureraccessdata.fda.gov
Label Or Tag, SterileLYV1Contract manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Contract manufactureraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Contract manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Contract manufactureraccessdata.fda.gov
Light, Surgical, Floor StandingFSS2Contract manufactureraccessdata.fda.gov
Locator, MagneticFTZ1Contract manufactureraccessdata.fda.gov
Loop, WireJYQ1Contract manufactureraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Contract manufactureraccessdata.fda.gov
MalletHXL1Contract manufactureraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Contract manufactureraccessdata.fda.gov
Marker, PeriodonticEMP1Contract manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Contract manufactureraccessdata.fda.gov
Mask, SurgicalFXX2Manufactureraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Contract manufactureraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Contract manufactureraccessdata.fda.gov
Microscope, SurgicalEPT1Contract manufactureraccessdata.fda.gov
Microscope, Surgical, General & Plastic SurgeryFSO1Contract manufactureraccessdata.fda.gov
Mirror, EntKAI1Contract manufactureraccessdata.fda.gov
Mirror, General & Plastic SurgeryFTX1Contract manufactureraccessdata.fda.gov
Mobilizer, EntKAJ1Contract manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Contract manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Pneumatic PoweredGET1Contract manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Contract manufactureraccessdata.fda.gov
Needle, CatheterGCB1Contract manufactureraccessdata.fda.gov
Needle, Gastro-UrologyFHR1Contract manufactureraccessdata.fda.gov
Needle, Neurosurgical SutureHAS1Contract manufactureraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Contract manufactureraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Contract manufactureraccessdata.fda.gov
Nipper, MalleusJYR1Contract manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Manufactureraccessdata.fda.gov
Orthosis, CervicalIQK1Contract manufactureraccessdata.fda.gov
OsteotomeHWM1Contract manufactureraccessdata.fda.gov
Osteotome, ManualGFI1Contract manufactureraccessdata.fda.gov
OtoscopeERA1Contract manufactureraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Contract manufactureraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Contract manufactureraccessdata.fda.gov
Packer, UterineHDM1Contract manufactureraccessdata.fda.gov
PasserHWQ1Contract manufactureraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Contract manufactureraccessdata.fda.gov
Pelvimeter, ExternalHER1Contract manufactureraccessdata.fda.gov
Pen, Marking, SurgicalHRP1Contract manufactureraccessdata.fda.gov
PercussorGWZ1Contract manufactureraccessdata.fda.gov
Perforator, AntrumKAT1Contract manufactureraccessdata.fda.gov
Perimeter, Automatic, Ac-PoweredHPT1Contract manufactureraccessdata.fda.gov
Pick, MassagingJET1Contract manufactureraccessdata.fda.gov
Pick, Microsurgical EarJYT1Contract manufactureraccessdata.fda.gov
PinwheelGWY1Contract manufactureraccessdata.fda.gov
Plier, CrimpFJY1Contract manufactureraccessdata.fda.gov
Plier, OrthodonticJEX1Contract manufactureraccessdata.fda.gov
Pliers, SurgicalHTC1Contract manufactureraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Contract manufactureraccessdata.fda.gov
Point, Silver, EndodonticEKL1Contract manufactureraccessdata.fda.gov
Positioner, SocketKIL1Contract manufactureraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Contract manufactureraccessdata.fda.gov
Post, Root CanalELR1Contract manufactureraccessdata.fda.gov
Preparer, Root Canal EndodonticEKQ1Contract manufactureraccessdata.fda.gov
Press, VeinJYW1Contract manufactureraccessdata.fda.gov
ProbeHXB1Contract manufactureraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Contract manufactureraccessdata.fda.gov
Probe, EntKAK1Contract manufactureraccessdata.fda.gov
Probe, Rectal, Non-PoweredEXX1Contract manufactureraccessdata.fda.gov
Probe, Uptake, NuclearIZD1Contract manufactureraccessdata.fda.gov
Protector, Skin PressureFMP1Contract manufactureraccessdata.fda.gov
Pump, Nebulizer, Electrically PoweredJPW1Contract manufactureraccessdata.fda.gov
Punch, AdenoidKBS1Contract manufactureraccessdata.fda.gov
Punch, AntrumKAW1Contract manufactureraccessdata.fda.gov
Punch, AtticJYX1Contract manufactureraccessdata.fda.gov
Punch, Biopsy, SurgicalEME1Contract manufactureraccessdata.fda.gov
Punch, EthmoidKAX1Contract manufactureraccessdata.fda.gov
Punch, Femoral NeckHWP1Contract manufactureraccessdata.fda.gov
Punch, NasalKAY1Contract manufactureraccessdata.fda.gov
Punch, SkullGXJ1Contract manufactureraccessdata.fda.gov
Punch, TonsilKBT1Contract manufactureraccessdata.fda.gov
Pusher, SocketHXO1Contract manufactureraccessdata.fda.gov
Rack, ClipHBR1Contract manufactureraccessdata.fda.gov
RaspHTR1Contract manufactureraccessdata.fda.gov
Rasp, EarJYY1Contract manufactureraccessdata.fda.gov
Rasp, Frontal-SinusKAZ1Contract manufactureraccessdata.fda.gov
Rasp, NasalKBA1Contract manufactureraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Contract manufactureraccessdata.fda.gov
ReamerHTO1Contract manufactureraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Contract manufactureraccessdata.fda.gov
Refractometer For Clinical UseJRE1Contract manufactureraccessdata.fda.gov
Restraint, Wheelchair, Non-ProtectiveKID1Contract manufactureraccessdata.fda.gov
Retainer, MatrixJEP1Contract manufactureraccessdata.fda.gov
Retainer, SurgicalGCZ1Contract manufactureraccessdata.fda.gov
Retention Device, SutureKGS1Contract manufactureraccessdata.fda.gov
RetractorGAD1Contract manufactureraccessdata.fda.gov
Retractor, EntKAL1Contract manufactureraccessdata.fda.gov
Retractor, FiberopticFDG1Contract manufactureraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Contract manufactureraccessdata.fda.gov
Retractor, Self-RetainingFFO1Contract manufactureraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Contract manufactureraccessdata.fda.gov
Retractor, VaginalHDL1Contract manufactureraccessdata.fda.gov
Ring CutterFNS1Contract manufactureraccessdata.fda.gov
Ring, LaparotomyFHI1Contract manufactureraccessdata.fda.gov
Rod, Measuring EarJYZ1Contract manufactureraccessdata.fda.gov
RongeurHTX1Contract manufactureraccessdata.fda.gov
Rongeur, ManualHAE2Contract manufactureraccessdata.fda.gov
Rongeur, MastoidJZA1Contract manufactureraccessdata.fda.gov
Rongeur, NasalKBB1Contract manufactureraccessdata.fda.gov
SawHSO1Contract manufactureraccessdata.fda.gov
Saw, NasalKBC1Contract manufactureraccessdata.fda.gov
Saw, Pneumatically PoweredKFK1Contract manufactureraccessdata.fda.gov
Saw, Powered, And AccessoriesHAB1Contract manufactureraccessdata.fda.gov
Scaler, PeriodonticEMN1Contract manufactureraccessdata.fda.gov
Scissors, EarJZB1Contract manufactureraccessdata.fda.gov
Scissors, EpisiotomyHDK1Contract manufactureraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Contract manufactureraccessdata.fda.gov
Scissors, NasalKBD1Contract manufactureraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Contract manufactureraccessdata.fda.gov
Scissors, UmbilicalHDJ1Contract manufactureraccessdata.fda.gov
Scissors, Wire Cutting, Ent, SterileJYA1Contract manufactureraccessdata.fda.gov
ScoopFHL1Contract manufactureraccessdata.fda.gov
Screw, OralKBW1Contract manufactureraccessdata.fda.gov
Screw, TonsilKBX1Contract manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufactureraccessdata.fda.gov
Searcher, MastoidJZC1Contract manufactureraccessdata.fda.gov
Set, Hollow MillHWL1Contract manufactureraccessdata.fda.gov
Set, Laryngeal InjectionKAA1Contract manufactureraccessdata.fda.gov
Sheet, BurnFPY1Contract manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Contract manufacturer, Manufactureraccessdata.fda.gov
Shield, Eye, RadiologicalIWS1Specification developeraccessdata.fda.gov
Shield, NippleHFS1Contract manufactureraccessdata.fda.gov
Shield, Protective, PersonnelKPY1Contract manufactureraccessdata.fda.gov
Skid, BoneHWO1Contract manufactureraccessdata.fda.gov
Sling, ArmILI1Contract manufactureraccessdata.fda.gov
Snare, EarJZD1Contract manufactureraccessdata.fda.gov
Snare, Non-ElectricalFGX1Contract manufactureraccessdata.fda.gov
Snare, SurgicalGAE1Contract manufactureraccessdata.fda.gov
Solution, Formalin-Alcohol-Acetic AcidIGF1Contract manufactureraccessdata.fda.gov
Solution, Lugol'SIAM1Contract manufactureraccessdata.fda.gov
Sound, Metal, InterconnectedFBS1Contract manufactureraccessdata.fda.gov
Sound, Urethral, Metal Or PlasticFBX1Contract manufactureraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Contract manufactureraccessdata.fda.gov
Spatula, OrthopedicHXR1Contract manufactureraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Contract manufactureraccessdata.fda.gov
Specula AccessoriesFXG1Contract manufactureraccessdata.fda.gov
Speculum, EntEPY1Contract manufactureraccessdata.fda.gov
Speculum, IlluminatedFXF1Contract manufactureraccessdata.fda.gov
Speculum, Non-IlluminatedFXE1Contract manufactureraccessdata.fda.gov
Speculum, RectalFFQ1Contract manufactureraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Contract manufactureraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Contract manufactureraccessdata.fda.gov
Splint, Extremity, Inflatable, ExternalFZF1Contract manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Contract manufactureraccessdata.fda.gov
Splint, NasalEPP1Contract manufactureraccessdata.fda.gov
Splint, TractionHSP1Contract manufactureraccessdata.fda.gov
Spoon, EarJZE1Contract manufactureraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Contract manufactureraccessdata.fda.gov
Stand, InfusionFOX1Contract manufactureraccessdata.fda.gov
Starter, Bone ScrewHWD1Contract manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Contract manufactureraccessdata.fda.gov
Stimulator, Caloric-AirKHH1Contract manufactureraccessdata.fda.gov

50 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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 20, 1997K970893ULTRASOUND TRANSDUCER DRAPEFYASubstantially EquivalentProtek Medical Products, Inc.accessdata.fda.gov
October 20, 1997K970889ULTRASOUND TRANSDUCER DRAPEKKXSubstantially EquivalentProtek Medical Products, Inc.accessdata.fda.gov
July 10, 1997K971722TRANS VAGINAL NEEDLE GUIDEITXSubstantially EquivalentProtek Medical Products, Inc.accessdata.fda.gov
June 13, 1997K971115GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDEITXSubstantially EquivalentProtek Medical Products, Inc.accessdata.fda.gov
March 28, 1994K934969DUALGARD FACE SHIELDFXXSubstantially EquivalentWhite Knight Healthcareaccessdata.fda.gov
April 7, 1989K891409PRECEPT MICRO-GARD LASER MASKFXXSubstantially EquivalentMars White Knightaccessdata.fda.gov
October 27, 1977K771409DISP. SURGICAL FACE MASKFXXSubstantially EquivalentPrecept, Inc.accessdata.fda.gov
March 23, 1977K770463MASK, SURGICAL, FACE, DISPOSABLEFXXSubstantially EquivalentPrecept, Inc.accessdata.fda.gov

Compare with other makers

Updated October 20, 1997. 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.