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
92329–92352 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1997
PMT NEW BEGINNINGS GELSHAPES & AMEND
K972597 · MDA
Pmt Corp.
General & Plastic Surgery · 82d
Cleared Oct 01, 1997
HELAX-VISIR
K972617 · IYE
Helax AB
Radiology · 84d
Cleared Oct 01, 1997
ULTRACELL SUCTION SPONGE
K972635 · GBX
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 79d
Cleared Oct 01, 1997
PRECEDENT REVISION HIP SYSTEM
K972637 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 78d
Cleared Oct 01, 1997
CRYOGEN CRYOSURGICAL SYSTEM
K972662 · GEH
Cryogen, Inc.
General & Plastic Surgery · 90d
Cleared Oct 01, 1997
ORIGIN LIGATOR DEVICE
K972685 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 76d
Cleared Oct 01, 1997
REDYROB-CLOSED WOUND DRAINAGE SYSTEM
K972703 · GCY
B.Braun Medical, Inc.
General & Plastic Surgery · 75d
Cleared Oct 01, 1997
CORE RESISTANT HUBER INFUSION SETS
K972712 · FPA
Icu Medical, Inc.
General Hospital · 72d
Cleared Oct 01, 1997
M-2 ANTERIOR PLATE SYSTEM
K972718 · KWQ
Acromed Corp.
Orthopedic · 72d
Cleared Oct 01, 1997
MIRAGE
K972886 · LLZ
Segami Corp., Inc.
Radiology · 57d
Cleared Oct 01, 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000...
K972891 · DKZ
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Oct 01, 1997
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K973054 · DNN
Emd Chemicals, Inc.
Toxicology · 47d
Cleared Oct 01, 1997
REP SPE VIS-60/40 KIT
K973316 · CEF
Helena Laboratories
Chemistry · 28d
Cleared Oct 01, 1997
NEEDLE GUIDE/GRID
K973362 · ITX
Protek Medical Products, Inc.
Radiology · 23d
Cleared Sep 30, 1997
ASAHI AM-R SERIES DIALYZERS
K970650 · MSE
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 222d
Cleared Sep 30, 1997
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
K970854 · DQO
Cordis Corp.
Cardiovascular · 204d
Cleared Sep 30, 1997
CATARACTSCREENER CT - S
K972440 · HKI
Neitz Instruments Company, Ltd.
Ophthalmic · 92d
Cleared Sep 30, 1997
ML-DISPOSABLE PAK
K972522 · MSR
Med-Logics, Inc.
Ophthalmic · 85d
Cleared Sep 30, 1997
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · HOZ
Deroyal Industries, Inc.
Ophthalmic · 74d
Cleared Sep 30, 1997
SUNGLASSES (NON-PRESCRIPTION)
K973407 · HQY
Pacific Optical Co. , Ltd.
Ophthalmic · 21d
Cleared Sep 30, 1997
SUNGLASSES
K973490 · HQY
Tong Yang Optical Co.
Ophthalmic · 15d
Cleared Sep 29, 1997
COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS
K964043 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 355d
Cleared Sep 29, 1997
MM-RUBY
K970475 · GEX
American Lasers, Inc.
General & Plastic Surgery · 234d
Cleared Sep 29, 1997
RELIANT CHARGER
K971768 · LKY
Walling Medical Equipment Co.
Gastroenterology & Urology · 139d