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
51289–51312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2010
BIOFOAM BONE WEDGE MODEL ASSORTED
K093950 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Jan 22, 2010
OSV II LOW FLOW LOW PRO VALVE
K093968 · JXG
Integra LifeSciences Corporation
Neurology · 30d
Cleared Jan 22, 2010
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
K093985 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 29d
Cleared Jan 22, 2010
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
K093986 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Jan 21, 2010
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
K090953 · OLO
Praxim Medivision, SA
Orthopedic · 293d
Cleared Jan 21, 2010
QUANTUM M COMPOSITE NAILING SYSTEM
K091425 · HSB
N.M.B. Medical Applications, Ltd.
Orthopedic · 253d
Cleared Jan 21, 2010
AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS
K091863 · FRO
Aubrey, Inc.
General & Plastic Surgery · 212d
Cleared Jan 21, 2010
ENDOFORM DERMAL TEMPLATE
K092096 · KGN
Mesynthes, Ltd.
General & Plastic Surgery · 191d
Cleared Jan 21, 2010
AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II
K092124 · KWQ
Trans1 Incorporated
Orthopedic · 190d
Cleared Jan 21, 2010
MEDLINE RED RUBBER URETHRAL CATHETER
K092250 · EYB
Medline Industries, Inc.
Gastroenterology & Urology · 177d
Cleared Jan 21, 2010
ENDURAVENT-5 VENTILATOR
K092263 · CBK
Providence Global Medical, Inc.
Anesthesiology · 177d
Cleared Jan 21, 2010
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM,...
K092388 · GXQ
Integra LifeSciences Corporation
Neurology · 169d
Cleared Jan 21, 2010
ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT
K093075 · GEI
Aragon Surgical, Inc.
General & Plastic Surgery · 113d
Cleared Jan 21, 2010
ODYSSEY WORKSTATION
K093092 · DQK
Stereotaxis, Inc.
Cardiovascular · 112d
Cleared Jan 21, 2010
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL:...
K093195 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 104d
Cleared Jan 21, 2010
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
K093217 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 100d
Cleared Jan 21, 2010
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
K093370 · KKO
Fu Hong Industries , Ltd.
Dental · 84d
Cleared Jan 21, 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
K093427 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d
Cleared Jan 21, 2010
DENTAL MERCURY
K093587 · ELY
Dmg USA, Inc.
Dental · 63d
Cleared Jan 21, 2010
FOGARTY OCCLUSION CATHETER
K093911 · MJN
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Jan 21, 2010
JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD)
K093918 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Jan 21, 2010
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V,...
K093919 · HCG
MicroVention, Inc.
Neurology · 30d
Cleared Jan 21, 2010
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S
K093944 · LZO
Medacta International S.A.
Orthopedic · 30d
Cleared Jan 21, 2010
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
K093947 · FGE
Merit Medical Systems, Inc.
Gastroenterology & Urology · 29d