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
88465–88488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1998
CIRCUIT GUARD
K982239 · CAH
Arc Medical, Inc.
General Hospital · 52d
Cleared Aug 14, 1998
DINAMAP MPS SELECT PORTABLE MONITOR
K982342 · MSX
Critikon Company, LLC
Cardiovascular · 39d
Cleared Aug 13, 1998
DUREX COLORS AND SCENTS
K980174 · HIS
London Intl., LLC
Obstetrics & Gynecology · 205d
Cleared Aug 13, 1998
GLYCACOR
K980888 · LCP
Exocell, Inc.
Chemistry · 157d
Cleared Aug 13, 1998
BW-1 (CODE NAME RD-0807)
K981244 · EJT
J.F. Jelenko & Co., Inc.
Dental · 129d
Cleared Aug 13, 1998
JELFINE-52 (CODE NAME RD-0901)
K981257 · EJS
J.F. Jelenko & Co., Inc.
Dental · 129d
Cleared Aug 13, 1998
PYRILINKS-D ASSAY KIT
K981364 · JMM
Metra Biosystems, Inc.
Chemistry · 120d
Cleared Aug 13, 1998
CLEARSTAR ENTERAL NUTRITION PUMP
K981541 · LZH
Frantz Medical Development, Ltd.
General Hospital · 106d
Cleared Aug 13, 1998
SINUSCOPE AND ACCESSORIES
K981751 · EOB
Henke Sass Wolf of America, Inc.
Ear, Nose, Throat · 87d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/4
K982150 · LLL
Theratest Laboratories, Inc.
Immunology · 56d
Cleared Aug 13, 1998
BI-DENT
K982229 · EKZ
Valley Forge Scientific Corp.
Dental · 90d
Cleared Aug 13, 1998
PREALBUMIN CALIBRATOR
K982292 · JIT
Dade Behring, Inc.
Chemistry · 44d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/5
K982622 · LLL
Theratest Laboratories, Inc.
Immunology · 56d
Cleared Aug 12, 1998
ANS 2000 ECG MONITOR AND RESPIRATION PACER
K973426 · DPS
D. E. Hokanson, Inc.
Cardiovascular · 336d
Cleared Aug 12, 1998
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
K980287 · KLK
Siemens Medical Solutions USA, Inc.
Anesthesiology · 198d
Cleared Aug 12, 1998
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · JOW
Dideco S.P.A.
Cardiovascular · 176d
Cleared Aug 12, 1998
BETTER-BLADDER (BB)
K981284 · DTN
Circulatory Technology, Inc.
Cardiovascular · 126d
Cleared Aug 12, 1998
ACS:CENTAUR CEA
K981478 · DHX
Chiron Diagnostics Corp.
Immunology · 110d
Cleared Aug 12, 1998
KSEA UNIMAT 45
K981703 · BTA
Karl Storz Endoscopy
General & Plastic Surgery · 90d
Cleared Aug 12, 1998
LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT...
K981782 · DYB
Arrow Intl., Inc.
Cardiovascular · 84d
Cleared Aug 12, 1998
ACS:CENTAUR PSA2 IMMUNOASSAY
K981839 · LTJ
Chiron Diagnostics Corp.
Immunology · 78d
Cleared Aug 12, 1998
STERILE SILICONE EXTERNAL WOUND COVER
K982065 · MIB
Specialty Surgical Products, Inc.
General & Plastic Surgery · 61d
Cleared Aug 12, 1998
MICROALBUSTIX REAGENT STRIPS
K982219 · JIR
Bayer Corp.
Chemistry · 49d
Cleared Aug 12, 1998
MARKWELL GAUZE SPONGE
K982260 · LWH
Markwell Intl., Inc.
General & Plastic Surgery · 47d