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
92185–92208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1997
50NG/ML COCAINE METABOLITE CALIBRATOR
K972835 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 28d
Cleared Aug 28, 1997
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
K972868 · JJY
Bionostics, Inc.
Chemistry · 24d
Cleared Aug 28, 1997
AURECAST 74
K972941 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 69d
Cleared Aug 28, 1997
AURECAST 83
K972942 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 69d
Cleared Aug 27, 1997
MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE
K964779 · GEI
Quantum Loop, Inc.
General & Plastic Surgery · 273d
Cleared Aug 27, 1997
NURSES BOUFFANT CAP
K965237 · LYU
Copioumed Intl., Inc.
General Hospital · 239d
Cleared Aug 27, 1997
Z TECH TRANSCUTANEOUS NEURAL STIMULATION
K965244 · GZJ
Z Technologies, LLC
Neurology · 246d
Cleared Aug 27, 1997
OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
K971166 · EWY
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 149d
Cleared Aug 27, 1997
POLY (VINYL) EXAM GLOVE, POWDERED
K971316 · LYZ
Copioumed Intl., Inc.
General Hospital · 140d
Cleared Aug 27, 1997
CYNOSURE DERMATOLOGY LASER COOLING TIP
K972002 · GEX
Cynosure, Inc.
General & Plastic Surgery · 89d
Cleared Aug 27, 1997
SHARPLAN EPITOUCH RUBY LASER SYSTEM
K972099 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 84d
Cleared Aug 27, 1997
BERGEN MODEL 500 ELECTROSURGERY GENERATOR
K972299 · GEI
Bergen Mfg.
General & Plastic Surgery · 69d
Cleared Aug 27, 1997
SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE
K972469 · FMI
Beech Medical Products, Inc.
General Hospital · 57d
Cleared Aug 27, 1997
KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING...
K972497 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 55d
Cleared Aug 27, 1997
THERMOGARD & THERMOGARD PLUS ABC
K972628 · GEI
Conmedcorp
General & Plastic Surgery · 44d
Cleared Aug 27, 1997
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K972970 · MKJ
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Aug 26, 1997
EVITA 2 DURA
K970165 · CBK
Drager, Inc.
Anesthesiology · 222d
Cleared Aug 26, 1997
TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
K970636 · IOQ
Hill-Rom, Inc.
Physical Medicine · 187d
Cleared Aug 26, 1997
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
K970836 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 183d
Cleared Aug 26, 1997
BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM
K970927 · ILK
Bruno Independent Living Aids, Inc.
Physical Medicine · 166d
Cleared Aug 26, 1997
SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
K971736 · GKZ
Sysmex Corp.
Hematology · 106d
Cleared Aug 26, 1997
BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER
K971763 · FMI
Retractable Technologies, Inc.
General Hospital · 105d
Cleared Aug 26, 1997
VALLEY FORGE BIPOLAR LOOP
K971986 · HGI
Valley Forge Scientific Corp.
Obstetrics & Gynecology · 89d
Cleared Aug 26, 1997
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
K972013 · KNA
National Healthcare Mfg. Corp.
Obstetrics & Gynecology · 88d