FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92689–92712 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1997
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE...
K970769 · DQA
Aristo Medical
Anesthesiology · 178d
Cleared Aug 28, 1997
FEMALE EXTERNAL URINARY COLLECTION POUCH
K971499 · EXI
Mediquest, Inc.
Gastroenterology & Urology · 125d
Cleared Aug 28, 1997
QUIKPAC II ONE STEP COCAINE TEST
K972059 · DIO
Drial Consultants, Inc.
Toxicology · 87d
Cleared Aug 28, 1997
INFUSASLEEVE IIA (IS-2A)
K972175 · QEY
Localmed, Inc.
Cardiovascular · 80d
Cleared Aug 28, 1997
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
K972359 · JSO
Remel, L.P.
Microbiology · 64d
Cleared Aug 28, 1997
AG CHEMISTRY ANALYZER SYSTEM
K972409 · JJG
Landmark Scientific, Inc.
Chemistry · 63d
Cleared Aug 28, 1997
SODIUM CHLORIDE INHALATION SOLUTION, USP
K972466 · CAF
Holopack International, LP
Anesthesiology · 58d
Cleared Aug 28, 1997
STERILE WATER FOR INHALATION, USP
K972467 · CAF
Holopack International, LP
Anesthesiology · 58d
Cleared Aug 28, 1997
RAICHEM PREALBUMIN SPIA
K972812 · DDS
Hemagen Diagnostics, Inc.
Immunology · 31d
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