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
38377–38400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2014
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB,...
K140080 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 100d
Cleared Apr 24, 2014
POLARIS SPINAL SYSTEM -TRANSLATION SCREW
K140123 · NKB
Ebi, LLC
Orthopedic · 98d
Cleared Apr 24, 2014
MONOFILAMENT POLYPECTOMY SNARE
K140763 · FDI
United States Endoscopy
Gastroenterology & Urology · 28d
Cleared Apr 23, 2014
EUM 100PRO
K131889 · OSP
Promedic, Inc.
Obstetrics & Gynecology · 302d
Cleared Apr 23, 2014
PATIENT MONITOR
K132077 · MHX
Advanced Instrumentations, Inc.
Cardiovascular · 292d
Cleared Apr 23, 2014
ACCUTIP COVER
K132549 · HKY
Accutome, Inc.
Ophthalmic · 252d
Cleared Apr 23, 2014
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
K132595 · HEB
Ontex Bvba
Obstetrics & Gynecology · 247d
Cleared Apr 23, 2014
NASAL MASK, NASAL MASK, FULL FACE MASK
K133009 · BZD
BMC Medical Co., Ltd.
Anesthesiology · 210d
Cleared Apr 23, 2014
XQ-1 INCUBATOR
K133742 · MQG
At Medical Uab
Obstetrics & Gynecology · 135d
Cleared Apr 23, 2014
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K133758 · HLI
Centervue S.P.A.
Ophthalmic · 133d
Cleared Apr 23, 2014
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
K133897 · OGZ
Infraredx, Inc.
Cardiovascular · 124d
Cleared Apr 23, 2014
FORTRESS PEDICLE SCREW SYSTEM
K140010 · NKB
Spineology, Inc.
Orthopedic · 111d
Cleared Apr 23, 2014
DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
K140445 · LLZ
Imaging Sciences International, LLC
Radiology · 61d
Cleared Apr 23, 2014
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND...
K140561 · PCU
Xlumena, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 22, 2014
INSTINCT
K132390 · HIS
Profilatex, S.A. DE C.V.
Obstetrics & Gynecology · 264d
Cleared Apr 22, 2014
HEPATIC VCAR
K133649 · JAK
GE Medical Systems SCS
Radiology · 146d
Cleared Apr 22, 2014
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
K133761 · IYN
Toshibamedical Systems Corporation
Radiology · 132d
Cleared Apr 22, 2014
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS&...
K133829 · FIP
Vivonic GmbH
Gastroenterology & Urology · 126d
Cleared Apr 22, 2014
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
K140147 · FRO
Bio-Medical Carbon Technology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Apr 22, 2014
MEDSOURCE SELECTABLE IV SET
K140442 · LHI
Medsource International, LLC
General Hospital · 60d
Cleared Apr 22, 2014
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM,...
K140560 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 48d
Cleared Apr 21, 2014
ALAMO T
K140303 · MAX
Alliance Partners, LLC
Orthopedic · 74d
Cleared Apr 21, 2014
ENVOY GUIDING CATHETER
K140307 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 73d
Cleared Apr 21, 2014
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
K140761 · HES
Carefusion 2200, Inc.
Obstetrics & Gynecology · 26d