Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
59449–59472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2007
TRIATHLON TS KNEE SYSTEM
K070095 · JWH
Howmedica Osteonics Corp.
Orthopedic · 142d
Cleared Jun 01, 2007
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL...
K070372 · DQY
Vascular Solutions, Inc.
Cardiovascular · 113d
Cleared Jun 01, 2007
BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
K070864 · MQV
Biomet Osteobiologics
Orthopedic · 65d
Cleared Jun 01, 2007
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
K070939 · FCM
Coloplast Manufacturing Us, LLC
Gastroenterology & Urology · 58d
Cleared Jun 01, 2007
VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110,...
K070991 · EBG
Vita
Dental · 53d
Cleared Jun 01, 2007
RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
K071086 · LLZ
Calgary Scientific, Inc.
Radiology · 45d
Cleared Jun 01, 2007
COLUMBUS TOTAL KNEE SYSTEM AS
K071220 · JWH
Aesculap Implant Systems, Inc.
Orthopedic · 30d
Cleared Jun 01, 2007
COPIOS BONE VOID FILLER SPONGE AND PASTE
K071237 · MQV
Kensey Nash Corp.
Orthopedic · 29d
Cleared Jun 01, 2007
MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP,...
K071246 · HCG
Micrus Endovascular Corporation
Neurology · 29d
Cleared Jun 01, 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071277 · CGX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071280 · CGX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
SYNCHRON SYSTEMS CREATININE REAGENT
K071283 · CGX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K071358 · NCX
Radiant Medical
Neurology · 17d
Cleared May 31, 2007
SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES
K062149 · DQA
International Business Strategies
Anesthesiology · 308d
Cleared May 31, 2007
LUBRINA, MODEL HIM-1
K070074 · EFB
J. Morita USA, Inc.
Dental · 143d
Cleared May 31, 2007
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
K070716 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 78d
Cleared May 31, 2007
ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
K071206 · MQV
Apatech , Ltd.
Orthopedic · 30d
Cleared May 30, 2007
OSSTAPLE, OSSPLATE, OSSFORCE
K061385 · KWQ
Biomedical Enterprises, Inc.
Orthopedic · 377d
Cleared May 30, 2007
THYROSAMPLER
K062979 · FCG
Acd Medical Innovation Corp.
Gastroenterology & Urology · 243d
Cleared May 30, 2007
CARDIOMEM CM 3000-12BT
K063042 · MWJ
Getemed Medizin- Und...
Cardiovascular · 239d
Cleared May 30, 2007
VISTA -S DEVICE
K070382 · MQP
Zimmer Trabecular Metal Technology
Orthopedic · 111d
Cleared May 30, 2007
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K070638 · KWP
Theken Spine, LLC
Orthopedic · 84d
Cleared May 30, 2007
ARAGON SURGICAL LAPCAP
K070651 · HIF
Aragon Surgical, Inc.
Obstetrics & Gynecology · 82d
Cleared May 30, 2007
DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
K070692 · MSH
Dukal Corporation
General Hospital · 78d