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
50881–50904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2010
OMNITECH LARGE, TRIMED COMPRESSION SCREW
K093676 · HWC
TriMed, Inc.
Orthopedic · 110d
Cleared Mar 17, 2010
GORE HYBRID VASCULAR GRAFT
K093934 · DSY
W.L. Gore & Associates
Cardiovascular · 85d
Cleared Mar 17, 2010
ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS
K093965 · LIT
C.R. Bard, Inc.
Cardiovascular · 84d
Cleared Mar 17, 2010
MODEL VISULAS 532S LASER WITH THE VITE OPTION
K100035 · GEX
Carl Zeiss Meditec, AG
General & Plastic Surgery · 70d
Cleared Mar 17, 2010
HARMONY VLED SURGICAL LIGHTNING SYSTEM
K100395 · FST
STERIS Corporation
General & Plastic Surgery · 29d
Cleared Mar 17, 2010
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K100520 · FIE
Nipro Medical Corporation
Gastroenterology & Urology · 22d
Cleared Mar 17, 2010
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
K100532 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 20d
Cleared Mar 17, 2010
VERSACLOSE, MODEL VC-200-01
K100572 · GAT
Anulex Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Mar 16, 2010
POLESTAR, MODEL N-30
K092308 · LNH
Medtronic Navigation Israel, Ltd.
Radiology · 229d
Cleared Mar 16, 2010
SCUBA BILIARY STENT SYSTEM
K092352 · FGE
Invatec S.P.A.
Gastroenterology & Urology · 224d
Cleared Mar 16, 2010
SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)
K092427 · LLZ
Albert Davydov Dds PC Professional
Radiology · 221d
Cleared Mar 16, 2010
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
K092825 · KWP
Spinecraft, Inc.
Orthopedic · 186d
Cleared Mar 16, 2010
OASIS MRI SYSTEM
K093044 · LNI
Hitachi Medical Systems America, Inc.
Radiology · 167d
Cleared Mar 16, 2010
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
K093066 · OWB
Infimed, Inc.
Radiology · 167d
Cleared Mar 16, 2010
VESISCAN
K093485 · IYO
Life-Tech, Inc.
Radiology · 127d
Cleared Mar 16, 2010
COOPDECH ENDOBRONCHIAL BLOCKER TUBE
K093888 · CBI
Daiken Medical Co, Ltd.
Anesthesiology · 88d
Cleared Mar 16, 2010
NEUROSCOUT STEERABLE GUIDEWIRE
K100351 · DQX
Codman & Shurtleff, Inc.
Cardiovascular · 32d
Cleared Mar 16, 2010
QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL:...
K100474 · GEX
Quicklase Limited
General & Plastic Surgery · 26d
Cleared Mar 16, 2010
IMPIX MANTA CERVICAL INTERBODY DEVICE
K100484 · ODP
Medicrea
Orthopedic · 26d
Cleared Mar 16, 2010
GYNECARE TVT EXACT CONTINENCE SYSTEM
K100485 · OTN
Ethicon, Inc.
Gastroenterology & Urology · 25d
Cleared Mar 16, 2010
LITEPAC, MODEL 682
K100490 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 25d
Cleared Mar 15, 2010
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091555 · NBW
Taidoc Technology Corporation
Chemistry · 292d
Cleared Mar 15, 2010
MESH GPS - LARGE, SMALL, SM, SM SMALL
K092726 · OQL
Surgical Structures , Ltd.
General & Plastic Surgery · 193d
Cleared Mar 15, 2010
MBCP+
K093122 · LYC
Biomatlante
Dental · 164d