FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
92569–92592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1997
MYRINGOTOMY TUBE
K972126 · ETD
Mednet Locator, Inc.
Ear, Nose, Throat · 54d
Cleared Jul 29, 1997
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972177 · LZA
Absolute Synthetic Technologies...
General Hospital · 49d
Cleared Jul 29, 1997
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972195 · LZA
Absolute Synthetic Technologies...
General Hospital · 48d
Cleared Jul 29, 1997
VISTA UNIVERSAL HANDPIECE
K972252 · HQC
Odyssey Technologies, Inc.
Ophthalmic · 43d
Cleared Jul 29, 1997
P3 UNIVERSAL PHACO HANDPIECE
K972253 · HQC
Odyssey Technologies, Inc.
Ophthalmic · 43d
Cleared Jul 29, 1997
GALLINI COAXIAL INTRODUCER
K972266 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 42d
Cleared Jul 29, 1997
LASER PERIPHERALS HOLMIUM BARE FIBERS
K972272 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 41d
Cleared Jul 29, 1997
DERMAMEND HYDROGEL GAUZE DRESSING
K972336 · KMF
Dermarx Corp.
General & Plastic Surgery · 36d
Cleared Jul 29, 1997
OVATION HDP
K972373 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 29, 1997
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND...
K972672 · ITX
Barzell-Whitmore Maroon Bells, Inc.
Radiology · 13d
Cleared Jul 28, 1997
FIRST MEDIC PULSE OXIMETRY MODULE
K955890 · MKJ
Colorado Medtech, Inc.
Cardiovascular · 577d
Cleared Jul 28, 1997
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
K963777 · KPJ
Stephenson Industries, Inc.
General & Plastic Surgery · 311d
Cleared Jul 28, 1997
A-V IMPULSE SYSTEM MODEL 6060
K964425 · JOW
Powell,Goldstein,Frazer & Murphy
Cardiovascular · 265d
Cleared Jul 28, 1997
CARD GUARD, MODEL CG-7100
K964836 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 241d
Cleared Jul 28, 1997
MM-1 MOVEMENT MONITOR
K971318 · GYD
Axon Instruments, Inc.
Neurology · 110d
Cleared Jul 28, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
K971604 · DSH
Alexander Mfg. Co.
Cardiovascular · 88d
Cleared Jul 28, 1997
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
K971695 · FMT
Fisher & Paykel Electronics , Ltd.
General Hospital · 81d
Cleared Jul 28, 1997
FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
K971744 · FXX
Berkley Medical Resources, Inc.
General Hospital · 77d
Cleared Jul 28, 1997
POWDER-FREE PATIENT EXAMINATION GLOVES
K971949 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 61d
Cleared Jul 28, 1997
FOSFOMYCIN, 200 MG, SENSI-DISC
K972098 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 54d
Cleared Jul 28, 1997
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES
K972291 · LYY
Allegiance Healthcare Corp.
General Hospital · 39d
Cleared Jul 28, 1997
TINAQUANT MYOGLOBIN ASSAY
K972513 · DDR
Boehringer Mannheim Corp.
Immunology · 21d
Cleared Jul 28, 1997
DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)
K972528 · FPO
Dyna Corp.
General Hospital · 21d
Cleared Jul 28, 1997
CARDIAC STATUS CONTROLS/TROPONIN I
K972687 · JJX
Spectral Diagnostics, Inc.
Chemistry · 11d