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
71041–71064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2003
RUBELLACOL
K031490 · LQN
Immunostics Inc.,
Microbiology · 65d
Cleared Jul 16, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
K031545 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 61d
Cleared Jul 16, 2003
BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM
K031679 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
K031880 · JIX
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Jul 16, 2003
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
K031890 · JJX
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Jul 16, 2003
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
K032092 · FCL
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 9d
Cleared Jul 15, 2003
SAFETY INTRODUCER NEEDLE
K030135 · DYB
B.Braun Medical, Inc.
Cardiovascular · 182d
Cleared Jul 15, 2003
B. BRAUN NERVE BLOCK CATHETER
K030830 · MEB
B.Braun Medical, Inc.
General Hospital · 123d
Cleared Jul 15, 2003
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
K030939 · BSZ
Philips Medical Systems
Anesthesiology · 112d
Cleared Jul 15, 2003
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING...
K031016 · DEH
The Binding Site, Ltd.
Immunology · 106d
Cleared Jul 15, 2003
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
K031044 · KNK
Clinical Data, Inc.
Toxicology · 105d
Cleared Jul 15, 2003
MAYO CLINIC BC-10 1.5T
K031119 · MOS
Mayo Medical Ventures
Radiology · 98d
Cleared Jul 15, 2003
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145 · EFB
Dentsply Intl.
Dental · 96d
Cleared Jul 15, 2003
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
K031201 · JWH
Ortho Development Corp.
Orthopedic · 90d
Cleared Jul 15, 2003
SAFETY RELEASE ARCH BAR KIT
K031207 · DYX
Casey Surgical, LLC
Dental · 90d
Cleared Jul 15, 2003
DBC PRESS ACUPUNCTURE NEEDLES
K031250 · MQX
Lhasa Medical, Inc.
General Hospital · 87d
Cleared Jul 15, 2003
AMERITEK SURE-POINT HDR NEEDLE TEMPLATE
K031273 · JAQ
Amertek Medical, Inc.
Radiology · 84d
Cleared Jul 15, 2003
FABIUS TIRO ANESTHESIA SYSTEM
K031400 · BSZ
Draeger Medical, Inc.
Anesthesiology · 71d
Cleared Jul 15, 2003
CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF
K031416 · DXQ
Clearmedical, Inc.
Cardiovascular · 71d
Cleared Jul 15, 2003
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
K031844 · LJT
Boston Scientific Corp
General Hospital · 29d
Cleared Jul 15, 2003
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
K031870 · LEG
Beckman Coulter, Inc.
Toxicology · 28d
Cleared Jul 14, 2003
INJECTOR
K023737 · MSS
Anton Meyer & Co. , Ltd.
Ophthalmic · 249d
Cleared Jul 14, 2003
SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J
K024007 · FOZ
Sunder Biomedical Tech. Co., Ltd.
General Hospital · 222d
Cleared Jul 14, 2003
ULTRAFLEX PRECISION COLONIC STENT
K030769 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 125d