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
140545–140568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1987
WAKO(TM) AUTOKIT LDH
K870401 · CFJ
Wako Chemicals USA, Inc.
Chemistry · 32d
Cleared Mar 06, 1987
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
K870461 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Mar 06, 1987
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500 · JIL
American Diagnostic Corp.
Chemistry · 30d
Cleared Mar 06, 1987
SUPER URINE ANALYZER SYSTEM
K870526 · KQO
Kyoto Daiichi Kagaku Co., Ltd.
Chemistry · 28d
Cleared Mar 06, 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
K870553 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Mar 06, 1987
GLUCOSE OXIDASE REAGENT
K870616 · CGA
Intersect Systems, Inc.
Chemistry · 22d
Cleared Mar 06, 1987
MICROBOND COMPOSITE KIT FOR CERAMIC BONDING SYSTEM
K870628 · EBF
Chem-E-Dent
Dental · 21d
Cleared Mar 06, 1987
OTOLOGICAL METRIC SCALE/GAUGE
K870757
Treace Medical, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 06, 1987
EAR APPLICATOR, CATALOG NO. 2229
K870762 · KXF
Treace Medical, Inc.
General Hospital · 8d
Cleared Mar 05, 1987
KIDNEY PERFUSION MACHINE
K864140 · KDN
Advanced Equipment Development, Inc.
Gastroenterology & Urology · 135d
Cleared Mar 05, 1987
CO2 LASER MICROMANIPULATOR
K864378 · HHR
Transamerican Technologies Intl.
Obstetrics & Gynecology · 120d
Cleared Mar 05, 1987
DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET
K870046 · HHR
Tti Medical
Obstetrics & Gynecology · 59d
Cleared Mar 05, 1987
AZTREONAM 30 MCG SENSITIVITY DISKS
K870347 · JTN
Difco Laboratories, Inc.
Microbiology · 36d
Cleared Mar 05, 1987
RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY
K870417 · FSM
North Coast Medi-Tek
General & Plastic Surgery · 30d
Cleared Mar 05, 1987
COSMEDTECH GENERAL ASPIRATOR
K870574 · HHI
Cosmedtech, Inc.
Obstetrics & Gynecology · 23d
Cleared Mar 04, 1987
PERSONAL/DERBY CONDOMS
K862401 · HIS
Razi Corp.
Obstetrics & Gynecology · 252d
Cleared Mar 04, 1987
MODEL 6110 IONTOPHORETIC APPLICATOR
K863166 · EGJ
Life-Tech Intl., Inc.
Physical Medicine · 198d
Cleared Mar 04, 1987
SERIES 620 RECTAL PROBE COVER
K864222 · ITX
General Electric Co.
Radiology · 127d
Cleared Mar 04, 1987
LACEY PRESS-FIT CONDYLAR TOTAL KNEE
K864518 · JWH
Dow Corning Wright
Orthopedic · 107d
Cleared Mar 04, 1987
502 OXYGEN SATURATION MONITOR
K864613 · DQA
Criticare Systems, Inc.
Anesthesiology · 100d
Cleared Mar 04, 1987
SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONS
K864648 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 98d
Cleared Mar 04, 1987
REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONS
K864649 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 98d
Cleared Mar 04, 1987
SLENDER REGULAR TAMPONS
K864650 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 98d
Cleared Mar 04, 1987
SUPER TAMPONS
K864651 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 98d