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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
140113–140136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1987
EMPI LOGIX MODEL 712 NMS, TENS
K870168 · GZJ
Empi
Neurology · 77d
Cleared Apr 01, 1987
IQ TSH IMMUNOASSAY
K870244 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 70d
Cleared Apr 01, 1987
AUTOPAK TSH MONOCLONAL IRMA KIT
K870245 · JLW
Micromedic Systems
Chemistry · 70d
Cleared Apr 01, 1987
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · FMG
Ohmeda Medical
General Hospital · 107d
Cleared Apr 01, 1987
PREFILLED RESPIRATORY THERAPY VIALS
K870332 · CCQ
Automatic Liquid Packaging, Inc.
Anesthesiology · 63d
Cleared Apr 01, 1987
(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE
K870355 · OCZ
Cook Urological, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 01, 1987
DIGOXIN (FPIA) CALIBRATOR KIT
K870389 · DLJ
Windsor Laboratories, Inc.
Toxicology · 61d
Cleared Apr 01, 1987
PHENOBARBITAL (FPIA) CALIBRATOR KIT
K870390 · DLJ
Windsor Laboratories, Inc.
Toxicology · 61d
Cleared Apr 01, 1987
NORTA (TM) UROBAG
K870504 · KNX
Beiersdorf, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 01, 1987
PHILIPS MODEL SL75-10 LINEAR ACCELERATOR
K870525 · IYE
Industrial Accelerator Co.
Radiology · 54d
Cleared Apr 01, 1987
TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG
K870586 · DIF
Medical Analysis Systems, Inc.
Toxicology · 49d
Cleared Apr 01, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
K870672 · JHI
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 41d
Cleared Apr 01, 1987
FRESENIUS HEMOFLOW F60 AND F80
K870724 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 01, 1987
SOFT TISSUE BIOPSY NEEDLE
K870785 · KNW
Bd Becton Dickinson Vacutainer...
Gastroenterology & Urology · 34d
Cleared Apr 01, 1987
REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000
K870790 · FTX
Lifestream Int'L, Inc.
General & Plastic Surgery · 34d
Cleared Apr 01, 1987
MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY
K870796 · FCE
Plasco, Inc.
Gastroenterology & Urology · 33d
Cleared Apr 01, 1987
CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY
K870833 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 29d
Cleared Apr 01, 1987
ATAC 1500 CHEMISTRY ANALYZER
K870836 · JJE
Turpen Laboratory Systems, Inc.
Chemistry · 29d
Cleared Apr 01, 1987
SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM
K870915 · HRX
C.R. Bard, Inc.
Orthopedic · 26d
Cleared Apr 01, 1987
DIGOXIN FPIA REAGENT SET
K870951 · KXT
Sigma Diagnostics, Inc.
Toxicology · 22d
Cleared Apr 01, 1987
PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
K870977 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 22d
Cleared Apr 01, 1987
SENSITESTER
K871167 · GWY
Dexin Pty. , Ltd.
Neurology · 8d
Cleared Apr 01, 1987
LUBRICATING JELLY
K871169 · KMJ
H & P Industries, Inc.
General Hospital · 8d
Cleared Mar 31, 1987
CARY BLAIR TRANSPORT MEDIUM
K864237 · JSM
Mds Laboratories, Inc.
Microbiology · 154d