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
91825–91848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 29, 1997
ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
K971794 · LRK
Frantz Design, Inc.
Dental · 137d
Cleared Sep 29, 1997
SOLITAIRE
K972101 · KLE
Heraeus Kulzer, Inc.
Dental · 117d
Cleared Sep 29, 1997
OPTIVIEW
K972520 · LLZ
Optimed Technologies, Inc.
Radiology · 84d
Cleared Sep 29, 1997
ADVANCE KNEE SYSTEM
K972626 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Sep 29, 1997
KINEMATIC POSITIONERS
K972704 · LNH
Ge Medical Systems, Inc.
Radiology · 73d
Cleared Sep 29, 1997
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
K972731 · KDJ
Klein-Baker Medical, Inc.
Gastroenterology & Urology · 69d
Cleared Sep 29, 1997
PROMEX ENT TISSUE REMOVAL SYSTEM
K972865 · ERL
Promex, Inc.
Ear, Nose, Throat · 56d
Cleared Sep 29, 1997
SA-EF MULTI-LUMEN EXTENSION SET
K972957 · FPA
Vlv Associates, Inc.
General Hospital · 49d
Cleared Sep 29, 1997
PROSTATE SPECIFIC ANTIGEN CONTROL
K973099 · JJX
Dade Chemistry Systems, Inc.
Immunology · 41d