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
58369–58392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2007
RESOLVE UVB PHOTOTHERAPY SYSTEM
K072035 · FTC
Allux Medical
General & Plastic Surgery · 83d
Cleared Oct 16, 2007
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS
K072454 · IYE
Integra Radionics, Inc.
Radiology · 46d
Cleared Oct 16, 2007
QUIKCLOT EX
K072474 · QSY
Z-Medica Corporation
General & Plastic Surgery · 42d
Cleared Oct 16, 2007
REALHAND HIGH DEXTERITY INSTRUMENTS
K072715 · GCJ
Novare Surgical Systems, Inc.
General & Plastic Surgery · 21d
Cleared Oct 16, 2007
NEUVIZ SPIRAL CT SCANNER SYSTEM
K072841 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 12d
Cleared Oct 15, 2007
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062447 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 419d
Cleared Oct 15, 2007
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K063788 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 298d
Cleared Oct 15, 2007
BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B,...
K070195 · ITX
Broadsound Corporation
Radiology · 266d
Cleared Oct 15, 2007
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
K070751 · MQV
Isotis Orthobiologics, Inc.
Orthopedic · 210d
Cleared Oct 15, 2007
AMNISCREEN HOME DETECTION LINER KIT
K071100 · CEN
Common Sense , Ltd.
Chemistry · 179d
Cleared Oct 15, 2007
PTS PANELS CHOL+HDL PANEL TEST STRIPS
K071593 · CHH
Polymer Technology Systems, Inc.
Chemistry · 126d
Cleared Oct 15, 2007
STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
K071888 · NHA
Straumann USA
Dental · 98d
Cleared Oct 15, 2007
PHENIX VERTEBRAL BODY REPLACEMENT
K072029 · MQP
New Business Development, LLC
Orthopedic · 83d
Cleared Oct 15, 2007
MODIFICATION TO TRIATHLON TS KNEE SYSTEM
K072221 · JWH
Howmedica Osteonics Corp.
Orthopedic · 66d
Cleared Oct 15, 2007
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
K072401 · LYZ
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 49d
Cleared Oct 15, 2007
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared Oct 15, 2007
VITEK 2 GRAM POSITIVE VANCOMYCIN
K072668 · LON
bioMerieux, Inc.
Microbiology · 24d
Cleared Oct 15, 2007
SMITH & NEPHEW ARTHROSCOPE
K072675 · HRX
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Oct 15, 2007
QUASAR BLUE LIGHT THERAPY SYSTEM
K072767 · GEX
Silver Bay, LLC
General & Plastic Surgery · 17d
Cleared Oct 12, 2007
ACON UTI URINARY TRACT INFECTION TEST STRIPS
K063295 · LJX
ACON Laboratories, Inc.
Chemistry · 345d
Cleared Oct 12, 2007
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
K070146 · CDQ
Horiba Abx
Chemistry · 269d
Cleared Oct 12, 2007
CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP),...
K070212 · DQX
Ovalum , Ltd.
Cardiovascular · 263d
Cleared Oct 12, 2007
GAMBRO CARTRIDGE BLOOD SETS
K070414 · FJK
Gambro Renal Products
Gastroenterology & Urology · 242d
Cleared Oct 12, 2007
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM
K070601 · DZE
Intra-Lock International
Dental · 224d