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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
53305–53328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2009
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
K081130 · DQY
Bridgepoint Medical
Cardiovascular · 388d
Cleared CT May 14, 2009
TEARLAB OSMOLARITY SYSTEM
K083184 · OND
Ocusense, Inc.
Chemistry · 198d
Cleared May 14, 2009
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
K083385 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 178d
Cleared May 14, 2009
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
K083648 · HSB
Efratgo, Ltd. HI Tech Bio-Surgical
Orthopedic · 156d
Cleared May 14, 2009
VITAL SIGNS MONITOR
K083821 · DQA
Edan Instruments, Inc.
Anesthesiology · 143d
Cleared May 14, 2009
BREAS VIVO 40 SYSTEM
K090113 · MNT
Breas Medical AB
Anesthesiology · 113d
Cleared CT May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT,...
K090413 · LCP
Bayer Healthcare, LLC
Chemistry · 85d
Cleared May 14, 2009
DVX SPINE SYSTEM
K090424 · MNH
Bk Meditech, Co., Ltd.
Orthopedic · 84d
Cleared May 14, 2009
AUTOSUTURE PROTACK
K090470 · OCW
Covidien
General & Plastic Surgery · 80d
Cleared May 14, 2009
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
K090489 · FTL
Kci USA, Inc.
General & Plastic Surgery · 78d
Cleared May 14, 2009
WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING...
K091073 · KPS
Ultraspect , Ltd.
Radiology · 30d
Cleared May 13, 2009
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
K081803 · DRF
St Jude Medical
Cardiovascular · 321d
Cleared May 13, 2009
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1
K091040 · FLL
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared May 13, 2009
ELITE MPX LASER SYSTEM WITH CRYO C
K091169 · GEX
Cynosure, Inc.
General & Plastic Surgery · 21d
Cleared May 12, 2009
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS...
K083214 · DQY
Aga Medical Corp.
Cardiovascular · 193d
Cleared May 12, 2009
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
K083838 · MNW
Fook Tin Technologies Limited
Gastroenterology & Urology · 140d
Cleared May 12, 2009
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K090187 · NBW
Taidoc Technology Corporation
Chemistry · 106d
Cleared May 12, 2009
LAMINOPLASTY PLATING SYSTEM
K090354 · NQW
Aesculap Implant System, Inc.
Orthopedic · 90d
Cleared May 12, 2009
SEGMENT
K090833 · LLZ
Medviso
Radiology · 47d
Cleared May 12, 2009
CRONO S-PID 50
K091042 · FRN
Cane S.R.L.
General Hospital · 29d
Cleared May 12, 2009
NMI PICC
K091261 · LJS
Navilyst Medical, Inc.
General Hospital · 13d
Cleared May 11, 2009
MULTI-CHANNEL LASER THERAPY SYSTEM
K082686 · ILY
United Integrated Services Co., Ltd.
Physical Medicine · 238d
Cleared May 11, 2009
REFINE LIFT SYSTEM
K083102 · FTL
Alure Medical, Inc.
General & Plastic Surgery · 203d
Cleared May 11, 2009
SOCKIT! AND MCMERLIN DERMAL WOUND GEL
K090092 · FRO
Mcmerlin Dental Products LP
General & Plastic Surgery · 117d