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
120889–120912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1991
AMCATH DISPOSABLE MICRO SCISSORS
K912605 · GCJ
Intl. Medical, Inc.
General & Plastic Surgery · 29d
Cleared Jul 10, 1991
ADVANCE SUTURE ABSORBABLE GUT SUTURE
K903174 · GAE
Advance Suture, Inc.
General & Plastic Surgery · 357d
Cleared Jul 10, 1991
SLEEP I/T-5 AND SLEEP I/T-8
K904432 · BZQ
Cns, Inc.
Anesthesiology · 285d
Cleared Jul 10, 1991
HORIZON XL
K911616 · DRT
Mennen Medical, Inc.
Cardiovascular · 90d
Cleared Jul 10, 1991
CERADELTA
K911671 · EJS
Metalor Dental USA Corp.
Dental · 90d
Cleared Jul 09, 1991
ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
K900385 · DSI
Parexel Intl. Corp.
Cardiovascular · 526d
Cleared Jul 09, 1991
MERIDIEN DENTAL SYSTEMS
K903488 · JEQ
Anco Merchandise Co., Ltd.
Dental · 342d
Cleared Jul 09, 1991
WATER COLUMN RELIEF VALVE
K904398 · CAF
Icn Pharmaceuticals, Inc.
Anesthesiology · 287d
Cleared Jul 09, 1991
BIOCERAM DENTAL IMPLANT, SERIES II
K904450 · DZE
Kyocera America, Inc.
Dental · 284d
Cleared Jul 09, 1991
CORDIS OPTA 5
K905698 · LIT
Cordis Corp.
Cardiovascular · 201d
Cleared Jul 09, 1991
GLOBAL CARE MICRO II
K910244 · GZJ
Globalcare Intl., Inc.
Neurology · 168d
Cleared Jul 09, 1991
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K910610 · JEQ
Bausch & Lomb, Inc.
Dental · 147d
Cleared Jul 09, 1991
ABL520 BLOOD GAS SYSTEM
K910827 · GHS
Radiometer America, Inc.
Hematology · 132d
Cleared Jul 09, 1991
NHS 2044P BODY AID, HEARING AID
K911183 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 113d
Cleared Jul 09, 1991
ILCO INFRARED LIGHT COAGULATOR
K911600 · KNS
Holl Meditronics, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 09, 1991
TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES
K911605 · DQO
Target Therapeutics
Cardiovascular · 90d
Cleared Jul 09, 1991
BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
K911606 · KDD
Baxter Healthcare Corp
General & Plastic Surgery · 90d
Cleared Jul 09, 1991
CAPIOX(R) BUBBLE TRAP
K911632 · KRL
Terumo Medical Corp.
Cardiovascular · 89d
Cleared Jul 09, 1991
ABIODENT PERIOTEMP(R) SYSTEM
K911643 · EIL
Abiomed, Inc.
Dental · 88d
Cleared Jul 09, 1991
COULTERCLONE
K911793 · GKZ
Coulter Immunology
Hematology · 78d
Cleared Jul 09, 1991
SPACE(TM) 7500
K912071 · IKN
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 60d
Cleared Jul 09, 1991
FX-CABLELOK SYSTEM
K912207 · JDQ
Biodynamic Technologies, Inc.
Orthopedic · 50d
Cleared Jul 09, 1991
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K912357 · KRX
R&D Systems, Inc.
Hematology · 42d
Cleared Jul 08, 1991
AIM TIBIAL NAIL
K911554 · HSB
Ace Medical Co.
Orthopedic · 90d