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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37705–37728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2014
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856 · KXK
C.R. Bard, Inc.
Radiology · 29d
Cleared May 01, 2014
SILVERLON ISLAND WOUND DRESSING
K122817 · FRO
Argentum Medical, LLC
General & Plastic Surgery · 594d
Cleared May 01, 2014
SUSTAIN
K131866 · HIS
Hollender Sustainable Brands, LLC
Obstetrics & Gynecology · 311d
Cleared May 01, 2014
STABILIZATION SCREW
K131920 · HWC
In2bones Sas
Orthopedic · 309d
Cleared May 01, 2014
OEC 9800 PLUS
K132027 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 304d
Cleared May 01, 2014
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K132637 · LYZ
Zibo Intco Medical Products Co., Ltd.
General Hospital · 251d
Cleared May 01, 2014
RESPIRATORY GAS HUMIDIFIER
K132857 · BTT
Pacific Medico Co., Ltd.
Anesthesiology · 231d
Cleared May 01, 2014
COLLACARE DENTAL
K133290 · KGN
Innocoll Pharmaceuticals
General & Plastic Surgery · 188d
Cleared May 01, 2014
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
K133418 · MAX
Seaspine, Inc.
Orthopedic · 175d
Cleared May 01, 2014
XCAGE INTERBODY FUSION SYSTEM
K133514 · MAX
Ouroboros Medical
Orthopedic · 167d
Cleared May 01, 2014
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
K133672 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 153d
Cleared May 01, 2014
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
K140185 · PDU
Avinger, Inc.
Cardiovascular · 97d
Cleared May 01, 2014
ORTHOPEDIC FIXATION SYSTEMS
K140216 · HRS
Impact Medical, LLC
Orthopedic · 93d
Cleared May 01, 2014
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I...
K140818 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Apr 30, 2014
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
K130065 · NFO
Biosonic Technologies, LLC
Neurology · 475d
Cleared Apr 30, 2014
MOSTDI DENTAL IMPLANT SYSTEM
K132178 · DZE
Mostdi Innovations Sdn Bhd
Dental · 289d
Cleared Apr 30, 2014
MEDTRONIC INPUT PS INTRODUCER
K132617 · DYB
Medtronic, Inc.
Cardiovascular · 252d
Cleared Apr 30, 2014
BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K133149 · FIP
Mar Cor Purification, Inc.
Gastroenterology & Urology · 195d
Cleared Apr 30, 2014
CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER
K133516 · CCK
Flexicare
Anesthesiology · 166d
Cleared Apr 30, 2014
FIAGON NAVIGATION SYSTEM
K133573 · PGW
Fiagon GmbH
Ear, Nose, Throat · 161d
Cleared Apr 30, 2014
SOMATOM PERSPECTIVE
K133590 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 159d
Cleared Apr 30, 2014
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
K133600 · DXT
Coeur, Inc.
Cardiovascular · 156d
Cleared Apr 30, 2014
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882 · DXJ
Ge Medical Systems Information...
Cardiovascular · 131d
Cleared Apr 30, 2014
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
K140959 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d