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
85681–85704 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1999
RAPIDONE - COCAINE TEST
K990822 · DIO
American Bio Medica Corp.
Toxicology · 126d
Cleared Jul 15, 1999
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS...
K991001 · DRF
Ep Medsystems
Cardiovascular · 112d
Cleared Jul 15, 1999
SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101
K991382 · GCJ
Genicon, LC
General & Plastic Surgery · 85d
Cleared Jul 15, 1999
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
K991389 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 85d
Cleared Jul 15, 1999
ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)
K991489 · ELW
Harry J. Bosworth Co.
Dental · 78d
Cleared Jul 15, 1999
ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)
K991490 · ELW
Harry J. Bosworth Co.
Dental · 78d
Cleared Jul 15, 1999
DYNAREX DRAIN SPONGE
K991694 · KMF
Dynarex Corp.
General & Plastic Surgery · 58d
Cleared Jul 15, 1999
DYNAREX NON-WOVEN SPONGE
K991695 · KMF
Dynarex Corp.
General & Plastic Surgery · 58d
Cleared Jul 15, 1999
N PROTEIN STANDARD UY
K991705 · JIT
Dade Behring, Inc.
Chemistry · 57d
Cleared Jul 15, 1999
TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
K992122 · LYZ
Maxxim Medical
General Hospital · 22d
Cleared Jul 14, 1999
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+...
K980380 · GWM
Diametrics Medical, Ltd.
Neurology · 527d
Cleared Jul 14, 1999
EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
K983660 · LHN
Brainlab, Inc.
Radiology · 268d
Cleared Jul 14, 1999
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K984563 · IWB
Accuray, Inc.
Radiology · 203d
Cleared Jul 14, 1999
SOLAR 9500 INFORMATION MONITOR
K990068 · MHX
General Electric Medical Systems...
Cardiovascular · 187d
Cleared Jul 14, 1999
ELECTRO MECHANICAL LITHOTRIPTOR
K990341 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 161d
Cleared Jul 14, 1999
INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI...
K990847 · MQH
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 121d
Cleared Jul 14, 1999
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52,...
K990941 · MQK
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 114d
Cleared Jul 14, 1999
REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
K991114 · DZE
Lifecore Biomedical, Inc.
Dental · 104d
Cleared Jul 14, 1999
STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
K991291 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 90d
Cleared Jul 14, 1999
BOVINE SERUM ALBUMIN (BSA)
K991338 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 14, 1999
PVP (POLYVINYLPYRROLIDONE)
K991343 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 14, 1999
SPIN SNAP-OFF SCREW
K991477 · HWC
New Deal, S.A.
Orthopedic · 77d
Cleared Jul 14, 1999
SMITH & NEPHEW SUTURE LOK
K991500 · OCW
Smith & Nephew Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 14, 1999
PRO-PORTION CLEANER/DISINFECTANT
K991509 · LRJ
Sultan Chemists, Inc.
General Hospital · 75d