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Data / Medical devices / United States / Sontec Instruments, Inc.

Sontec Instruments, Inc.: FDA-registered device maker in Centennial, CO, United States, 25 510(k) clearances

Sontec Instruments, Inc. is registered with the FDA (registration 1720747) in Centennial, CO, United States. It lists 210 device types. The FDA files 25 510(k) clearances under its listings, the newest dated January 22, 2016. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Sontec Instruments, Inc.
FDA registration number
1720747
Address
7248 S Tucson Way, Centennial, CO, United States, 80112
Owner or operator
SONTEC INSTRUMENTS, INC. (1720747)
Roles
Repackager or relabeler
First device listed
July 20, 1992
Registered through
2027
Brand names listed
,GENERAL, AB Bipolar Cable/Cord, ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE, ADENOID PUNCH, ALL TYPES OF RETRACTORS, APPLIER, STAPLE, SURGICAL,, ASPIRAITON AND INJECTION, BINOCULAR and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Repackager or relabeleraccessdata.fda.gov
Applier, Hemostatic ClipHBT1Repackager or relabeleraccessdata.fda.gov
Applier, Staple, Surgical,GEF1Repackager or relabeleraccessdata.fda.gov
AwlHWJ1Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Repackager or relabeleraccessdata.fda.gov
Blood Pressure CuffDXQ2Repackager or relabeleraccessdata.fda.gov
Blower, Powder, EntKCL1Repackager or relabeleraccessdata.fda.gov
Bone MillLYS1Repackager or relabeleraccessdata.fda.gov
Brush, Biopsy, General & Plastic SurgeryGEE1Repackager or relabeleraccessdata.fda.gov
Burnisher, OperativeEKJ1Repackager or relabeleraccessdata.fda.gov
Burr, Corneal, Battery Powered, Rust Ring RemovalOHW1Repackager or relabeleraccessdata.fda.gov
Burr, Corneal, Battery-PoweredHOG1Repackager or relabeleraccessdata.fda.gov
Burr, OrthopedicHTT1Repackager or relabeleraccessdata.fda.gov
CaliperKTZ1Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Repackager or relabeleraccessdata.fda.gov
Cannula, OphthalmicHMX1Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Carver, Dental Amalgam, OperativeEKH1Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Repackager or relabeleraccessdata.fda.gov
Chisel (Osteotome)KDG1Repackager or relabeleraccessdata.fda.gov
Chisel, NasalKAN1Repackager or relabeleraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Repackager or relabeleraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Repackager or relabeleraccessdata.fda.gov
ClampHXD1Repackager or relabeleraccessdata.fda.gov
Clamp, CircumcisionHFX2Repackager or relabeleraccessdata.fda.gov
Clamp, Muscle, OphthalmicHOB1Repackager or relabeleraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Repackager or relabeleraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Repackager or relabeleraccessdata.fda.gov
Clamp, VascularDXC2Repackager or relabeleraccessdata.fda.gov
Collagen Corneal ShieldMOE1Repackager or relabeleraccessdata.fda.gov
Condenser, Amalgam And Foil, OperativeEKG1Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Repackager or relabeleraccessdata.fda.gov
Curette, AdenoidKBJ1Repackager or relabeleraccessdata.fda.gov
Curette, EarJYG1Repackager or relabeleraccessdata.fda.gov
Curette, NasalKAP1Repackager or relabeleraccessdata.fda.gov
Curette, OphthalmicHNZ1Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, DentalEMK1Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Repackager or relabeleraccessdata.fda.gov
Cutter, SurgicalFZT1Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
CystotomeHNY1Repackager or relabeleraccessdata.fda.gov
Depressor, OrbitalHNX1Repackager or relabeleraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Repackager or relabeleraccessdata.fda.gov
Device, Locking, For Intestinal ClampFFR1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Dilator, TrachealKCG1Repackager or relabeleraccessdata.fda.gov
Dilator, UrethralKOE2Repackager or relabeleraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Repackager or relabeleraccessdata.fda.gov
Driver, Surgical, PinGFC1Repackager or relabeleraccessdata.fda.gov
Dynamometer, NonpoweredHRW1Repackager or relabeleraccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
ElevatorHTE1Repackager or relabeleraccessdata.fda.gov
Elevator, EntKAD1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Repackager or relabeleraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Repackager or relabeleraccessdata.fda.gov
ExtractorHWB1Repackager or relabeleraccessdata.fda.gov
File, Bone, SurgicalEMI1Repackager or relabeleraccessdata.fda.gov
File, PeriodonticEMR1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Repackager or relabeleraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Repackager or relabeleraccessdata.fda.gov
Fork, TuningGWX1Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Repackager or relabeleraccessdata.fda.gov
Goniometer, NonpoweredKQW1Repackager or relabeleraccessdata.fda.gov
Gouge, Nasal, EntKAQ1Repackager or relabeleraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Repackager or relabeleraccessdata.fda.gov
Guide, Drill, LigamentLXI1Repackager or relabeleraccessdata.fda.gov
Hammer, SurgicalFZY1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Handpiece (Brace), DrillHBD1Repackager or relabeleraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Repackager or relabeleraccessdata.fda.gov
HemostatHRQ1Repackager or relabeleraccessdata.fda.gov
Hemostat, SurgicalEMD1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Repackager or relabeleraccessdata.fda.gov
Hook, BoneKIK1Repackager or relabeleraccessdata.fda.gov
Hook, Gastro-UrologyFHB1Repackager or relabeleraccessdata.fda.gov
Hook, Microsurgical EarJYL1Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Repackager or relabeleraccessdata.fda.gov
ImpactorHWA1Repackager or relabeleraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Repackager or relabeleraccessdata.fda.gov
Instrument, CompressionHWN1Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Repackager or relabeleraccessdata.fda.gov
Introducer, SphereHNP1Repackager or relabeleraccessdata.fda.gov
Knife, EarJYO1Repackager or relabeleraccessdata.fda.gov
Knife, EntKTG1Repackager or relabeleraccessdata.fda.gov
Knife, NasalKAS1Repackager or relabeleraccessdata.fda.gov
Knife, OrthopedicHTS1Repackager or relabeleraccessdata.fda.gov
Knife, SurgicalEMF1Repackager or relabeleraccessdata.fda.gov
Label Or Tag, SterileLYV1Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Repackager or relabeleraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
Lens, Condensing, DiagnosticHJL1Repackager or relabeleraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Repackager or relabeleraccessdata.fda.gov
Loupe, Binocular, Low PowerHJH1Repackager or relabeleraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Repackager or relabeleraccessdata.fda.gov
MalletHXL1Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Repackager or relabeleraccessdata.fda.gov
Marker, ScleraHMQ1Repackager or relabeleraccessdata.fda.gov
Mirror, EntKAI1Repackager or relabeleraccessdata.fda.gov
Mirror, General & Plastic SurgeryFTX1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeleraccessdata.fda.gov
Ophthalmoscope, Ac-PoweredHLI2Repackager or relabeleraccessdata.fda.gov
Ophthalmoscope, Battery-PoweredHLJ2Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
OsteotomeHWM1Repackager or relabeleraccessdata.fda.gov
Osteotome, ManualGFI1Repackager or relabeleraccessdata.fda.gov
OtoscopeERA1Repackager or relabeleraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Repackager or relabeleraccessdata.fda.gov
Pick, Microsurgical EarJYT1Repackager or relabeleraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Repackager or relabeleraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Repackager or relabeleraccessdata.fda.gov
PinwheelGWY1Repackager or relabeleraccessdata.fda.gov
Pliers, SurgicalHTC1Repackager or relabeleraccessdata.fda.gov
ProbeHXB1Repackager or relabeleraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Repackager or relabeleraccessdata.fda.gov
Probe, EntKAK1Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Probe, PeriodonticEIX1Repackager or relabeleraccessdata.fda.gov
Punch, AdenoidKBS1Repackager or relabeleraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Repackager or relabeleraccessdata.fda.gov
Punch, EntKTF1Repackager or relabeleraccessdata.fda.gov
Punch, NasalKAY1Repackager or relabeleraccessdata.fda.gov
Punch, SkullGXJ1Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
RaspHTR1Repackager or relabeleraccessdata.fda.gov
Rasp, EarJYY1Repackager or relabeleraccessdata.fda.gov
Rasp, NasalKBA1Repackager or relabeleraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Repackager or relabeleraccessdata.fda.gov
Restraint, ProtectiveFMQ1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Retractor, EntKAL1Repackager or relabeleraccessdata.fda.gov
Retractor, FiberopticFDG1Repackager or relabeleraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Repackager or relabeleraccessdata.fda.gov
Retractor, OphthalmicHNI1Repackager or relabeleraccessdata.fda.gov
Retractor, Self-RetainingFFO1Repackager or relabeleraccessdata.fda.gov
Retractor, VaginalHDL1Repackager or relabeleraccessdata.fda.gov
Ring CutterFNS1Repackager or relabeleraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeleraccessdata.fda.gov
Rongeur, NasalKBB1Repackager or relabeleraccessdata.fda.gov
SawHSO1Repackager or relabeleraccessdata.fda.gov
Saw, Manual And AccessoriesGDR1Repackager or relabeleraccessdata.fda.gov
Saw, NasalKBC1Repackager or relabeleraccessdata.fda.gov
Scaler, PeriodonticEMN1Repackager or relabeleraccessdata.fda.gov
Scissors, EarJZB1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, NasalKBD1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Repackager or relabeleraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Repackager or relabeleraccessdata.fda.gov
Scissors, Wire Cutting, Ent, Non-SterileNNU1Repackager or relabeleraccessdata.fda.gov
ScoopFHL1Repackager or relabeleraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Snare, NasalKBE1Repackager or relabeleraccessdata.fda.gov
Snare, Non-ElectricalFGX1Repackager or relabeleraccessdata.fda.gov
Sound, Urethral, Metal Or PlasticFBX1Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Repackager or relabeleraccessdata.fda.gov
Spatula, OphthalmicHND1Repackager or relabeleraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Repackager or relabeleraccessdata.fda.gov
Specula, OphthalmicHNC1Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Repackager or relabeleraccessdata.fda.gov
Speculum, Non-IlluminatedFXE1Repackager or relabeleraccessdata.fda.gov
Speculum, RectalFFQ1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Spoon, OphthalmicHNB1Repackager or relabeleraccessdata.fda.gov
Spud, OphthalmicHNA1Repackager or relabeleraccessdata.fda.gov
Stabilizer, HeartMWS1Repackager or relabeleraccessdata.fda.gov
Staple, Removable (Skin)GDT1Repackager or relabeleraccessdata.fda.gov
Stethoscope, ManualLDE1Repackager or relabeleraccessdata.fda.gov
Stripper, Vein, ReusableGAI1Repackager or relabeleraccessdata.fda.gov
Syringe, EntKCP1Repackager or relabeleraccessdata.fda.gov
TampHXG1Repackager or relabeleraccessdata.fda.gov
Tap, BoneHWX1Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager or relabeleraccessdata.fda.gov
Transilluminator, Fiber OpticMQW1Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
TrephineHWK1Repackager or relabeleraccessdata.fda.gov
Trephine, Manual, OphthalmicHRH1Repackager or relabeleraccessdata.fda.gov
Trocar, EntKTE1Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Repackager or relabeleraccessdata.fda.gov
Twister, WireHXS1Repackager or relabeleraccessdata.fda.gov
Unit, Cryosurgical, AccessoriesGEH2Repackager or relabeleraccessdata.fda.gov
Unit, Examining/Treatment, EntETF1Repackager or relabeleraccessdata.fda.gov

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
January 22, 2016K152400General & Plastic Surgery InstrumentsGCJSubstantially EquivalentSontec Instruments, Inc.accessdata.fda.gov
May 18, 2015K142486HEINE BETA 200, HEINE BETA 200 S, HEINE K 180HLJSubstantially EquivalentHeine Optotechnik GmbH & Co. KGaccessdata.fda.gov
May 14, 2013K123077VASCULAR CLAMPSDXCSubstantially EquivalentHebumedical GmbHaccessdata.fda.gov
February 26, 2013K123316HEINE OMEGA 500HLISubstantially EquivalentHeine Optotechnik GmbH & Co. KGaccessdata.fda.gov
December 20, 2011K102921ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIESGEISubstantially EquivalentBema-GmbH & Co. KGaccessdata.fda.gov
October 6, 2010K102006CRYOMEGAGEHSubstantially EquivalentStc Consulting, LLCaccessdata.fda.gov
September 10, 2010K100736KIRSCHNER AND GUIDE WIRESHTYSubstantially EquivalentSmt Schilling Metalltechnik GmbHaccessdata.fda.gov
August 31, 2010K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWPSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
August 27, 2010K101892HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-DXQSubstantially EquivalentHeine Optotechnik GmbH & Co. KGaccessdata.fda.gov
June 21, 2010K101080NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXXGEISubstantially EquivalentEgon Faulhaber Surgical Instruments Pinzettenaccessdata.fda.gov
October 26, 2009K092544INSTRUMED VASCULAR CLAMPSDXCSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
January 9, 2008K072834SIBEL SA VASCULAR CLAMPDXCSubstantially EquivalentSurgical Instruments Belgium SAaccessdata.fda.gov
July 29, 2005K051429CLARIS NON-STICK BIPOLAR FORCEPSGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
May 13, 2004K033003SUCTION COAGULATORGEISubstantially EquivalentModern Medical Equipment Mfg., Ltd.accessdata.fda.gov
April 9, 2004K040052FINE SURGICAL CIRCUMCISION CLAMPHFXSubstantially EquivalentFine Surgical Instrument Corp.accessdata.fda.gov
July 11, 2002K021817AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240VGEISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
February 25, 2002K014201AARON REUSABLE ELECTROSURGICAL ELECTRODEGEISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
February 5, 2001K002877MICTEC ENDOSCOPES AND ACCESSORIESGEISubstantially EquivalentDufner Instrumente GmbHaccessdata.fda.gov
December 22, 2000K001955AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250GEISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
April 19, 2000K000961AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECEGEISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
March 4, 1999K984352AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPRGEISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
September 19, 1997K972901AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEISubstantially EquivalentAmerican Biosurgical, Inc.accessdata.fda.gov
March 21, 1995K942986ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)HGISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
February 16, 1994K93133816 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)HGISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
April 25, 1984K840433REPLACE-A-TIP HIGH TEMP. CAUTERYGEISubstantially EquivalentSuncoast Medical Manufacturers, Inc.accessdata.fda.gov

Compare with other makers

Updated January 22, 2016. 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.