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
145993–146016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1985
OMNIGRAPH 4000(ELECTROCARDIOGRAPH)
K852652 · DRS
Telemed Div.
Cardiovascular · 151d
Cleared Nov 19, 1985
CARDIORATER CR7
K852910 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 133d
Cleared Nov 19, 1985
LIGHT CURE FILLING MATERIAL
K853055 · EBF
Foremost Dental Mfg., Inc.
Dental · 123d
Cleared Nov 19, 1985
AXICARE CM-14 AUTOMATIC BREAST PUMP
K853107 · HGX
Crystal Medical Products, Inc.
Obstetrics & Gynecology · 119d
Cleared Nov 19, 1985
WATER DRIVEN BREAST PUMP BY BABY NURSE
K853326 · HGX
Baby Nurse
Obstetrics & Gynecology · 103d
Cleared Nov 19, 1985
WALLACH ZOOM COLPOSCOPE
K853389 · HEX
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 98d
Cleared Nov 19, 1985
JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2
K853470 · IYX
Toshiba Medical Systems
Radiology · 92d
Cleared Nov 19, 1985
DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES
K853707 · EIH
Dentsply Intl.
Dental · 76d
Cleared Nov 19, 1985
MULLER SELF LOCKING TOTAL HIP
K853768 · JDI
Protek, Inc.
Orthopedic · 71d
Cleared Nov 19, 1985
ALLOY B
K853845 · EJH
North American Alloys, Inc.
Dental · 64d
Cleared Nov 19, 1985
MULTISCAN 7
K853852 · ITX
Multiscan, Inc.
Radiology · 64d
Cleared Nov 19, 1985
CONICAL COLLAR HIP PROSTHESIS
K854046 · JDI
Kirschner Medical Corp.
Orthopedic · 48d
Cleared Nov 19, 1985
I.C.L.S. COMPULYZER
K854055 · JJG
Integrated Computerized Laboratory...
Chemistry · 47d
Cleared Nov 19, 1985
KIRSCHNER COMPRESSION HIP SCREW SYSTEM
K854205 · KTT
Kirschner Medical Corp.
Orthopedic · 34d
Cleared Nov 19, 1985
ES 22
K854243 · JJE
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Nov 19, 1985
CHEMPRO 1000
K854260 · CGA
Sen Tech Medical Corp.
Chemistry · 27d
Cleared Nov 19, 1985
PLEUR-EVAC II AUTOTRANSFUSION SYSTEM
K854301 · CAC
Deknatel, Inc.
Anesthesiology · 25d
Cleared Nov 19, 1985
MR 700 MICROPLATE READER 012-700-1000
K854303 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 25d
Cleared Nov 19, 1985
WIRE CUTTING PLIERS OR LINEMAN'S PLIERS
K854390 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 19d
Cleared Nov 19, 1985
ADULT ABSORBENT INCONTINENT BRIEF
K854408 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 18d
Cleared Nov 19, 1985
ROUND SUCTION DRAIN
K854418 · GBS
Sil-Med Corp.
General & Plastic Surgery · 15d
Cleared Nov 19, 1985
KIRSCHNER BONE FIXATION FASTENER SYSTEM
K854445 · JDR
Kirschner Medical Corp.
Orthopedic · 14d
Cleared Nov 19, 1985
URINARY DRAINAGE BAG
K854480 · KNX
The West Co., Inc.
Gastroenterology & Urology · 12d
Cleared Nov 18, 1985
ISOVOL-EXCHANGE TRAY
K852167 · BRZ
Rocky Mountain Medical Corp.
General Hospital · 182d