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
88969–88992 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1998
SOLUTION ADMINISTRATION SET
K981792 · FPA
Baxter Healthcare Corp
General Hospital · 88d
Cleared Aug 14, 1998
GB-1002 TENS WITH MASSAGE
K964437 · GZJ
Skylark Device Co., Ltd.
Neurology · 647d
Cleared Aug 14, 1998
DISCAM DIGITAL IMAGING SYSTEM
K974535 · HKI
Marcher Enterprises, Ltd.
Ophthalmic · 255d
Cleared Aug 14, 1998
ASTHMA MONITOR AM2
K980876 · BZG
Erich Jaeger GmbH & Co. KG
Anesthesiology · 161d
Cleared Aug 14, 1998
FLAPMAKER DISPOSABLE MICROKERATOME
K981155 · HNO
Hawken Industries
Ophthalmic · 136d
Cleared Aug 14, 1998
SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
K981761 · GKL
Sysmex Corp.
Hematology · 87d
Cleared Aug 14, 1998
CAROLINE GUIDE
K981809 · HAW
Surgical Solutions, Inc.
Neurology · 85d
Cleared Aug 14, 1998
NOSEBLEED NOSECLIP
K981966 · EMX
Michael M. Knott, M.D.
Ear, Nose, Throat · 71d
Cleared Aug 14, 1998
BC 900 SLIT LAMP
K982057 · HJO
Haag-Streit AG
Ophthalmic · 64d
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