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

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176,076 results
65641–65664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2005
REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER
K050995 · OBJ
Volcano Corporation
Cardiovascular · 61d
Cleared Jun 20, 2005
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A
K051021 · DXQ
Shanghai Lord International Trade...
Cardiovascular · 59d
Cleared Jun 20, 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051154 · LYZ
Hebei Manful Import & Export Co., Ltd.
General Hospital · 47d
Cleared Jun 20, 2005
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE...
K051317 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 31d
Cleared Jun 20, 2005
PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000
K051367 · MHX
Ge Medical Systems Information...
Cardiovascular · 26d
Cleared Jun 20, 2005
SENTINEL CHOLINESTERASE LIQUID
K051444 · DIH
Sentinel Ch. Srl
Toxicology · 18d
Cleared Jun 20, 2005
NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND...
K051563 · KGO
Terang Nusa Sdn Bhd
General Hospital · 7d
Cleared Jun 17, 2005
POLYGRAFT BGS
K041382 · JDK
Osteobiologics, Inc.
Orthopedic · 388d
Cleared Jun 17, 2005
ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
K043176 · HWC
Arc Surgical, LLC
Orthopedic · 213d
Cleared Jun 17, 2005
WHS-1000 WOUND HEALING SYSTEM
K050156 · KPJ
Iyia Technologies, Inc.
General & Plastic Surgery · 144d
Cleared Jun 17, 2005
AMS COLLAGEN DERMAL MATRIX
K050445 · PAG
American Medical Systems, Inc.
General & Plastic Surgery · 115d
Cleared Jun 17, 2005
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
K050456 · DXT
Medrad, Inc.
Cardiovascular · 114d
Cleared Jun 17, 2005
MEDLITE C1 Q-SWITCHED ND:YAG LASER
K050696 · GEX
Hoya Photonics, Inc.
General & Plastic Surgery · 91d
Cleared Jun 17, 2005
IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
K050847 · IPF
Theratech, Inc.
Physical Medicine · 74d
Cleared Jun 17, 2005
PARALLAX ACRYLIC RESIN WITH TRACERS TA
K050864 · NDN
Arthrocare Corp.
Orthopedic · 73d
Cleared Jun 17, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
K051196 · MQP
Implex Corp.
Orthopedic · 38d
Cleared Jun 17, 2005
POLYFORM SYNTHETIC MESH
K051245 · OTO
Proxy Biomedical , Ltd.
Obstetrics & Gynecology · 32d
Cleared Jun 17, 2005
ZODIAC SPINAL FIXATION SYSTEM
K051286 · MNH
Alphatec/Nexmed
Orthopedic · 30d
Cleared Jun 17, 2005
ELECSYS RBC FOLATE HEMOLYZED REAGENT
K051292 · CGN
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Jun 17, 2005
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K051306 · LXT
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jun 17, 2005
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)
K051318 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 28d
Cleared Jun 17, 2005
PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
K051379 · FGE
Ev3 Corporation
Gastroenterology & Urology · 21d
Cleared Jun 17, 2005
THE INCOURAGE SYSTEM
K051383 · BYI
Respiratory Technologies, Incorporated
Anesthesiology · 21d
Cleared Jun 17, 2005
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
K051432 · CIG
Arkray, Inc.
Chemistry · 16d