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
44137–44160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2012
AMISTEM AND QUADRA - LINE EXTENSION
K121011 · LZO
Medacta International
Orthopedic · 66d
Cleared Jun 08, 2012
SCENIUM 2.0
K121074 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 60d
Cleared Jun 08, 2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA...
K121402 · LIT
Trireme Medical, Inc.
Cardiovascular · 29d
Cleared Jun 08, 2012
PAX-FLEX3D, PHT-7000
K121412 · OAS
VATECH Co., Ltd.
Radiology · 28d
Cleared Jun 08, 2012
BELLYBOARD, SBRT ACCESSORIES
K121545 · LNH
Medtec Inc. Dba Civco Medical Solutions
Radiology · 14d
Cleared Jun 08, 2012
Q-FLO CLOSED MALE LUER CONNECTOR
K121554 · FPA
Us Fusion, LLC. Dba Truecare...
General Hospital · 14d
Cleared Jun 07, 2012
BAHADIR STERILIZATION TRAYS
K112090 · KCT
Bahadir USA Corp.
General Hospital · 322d
Cleared Jun 07, 2012
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM,...
K112607 · NKB
Spinevision S.A.
Orthopedic · 274d
Cleared Jun 07, 2012
CAPSURE(R) PS SYSTEM
K120646 · MNI
Spine Wave, Inc.
Orthopedic · 97d
Cleared Jun 07, 2012
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · QEZ
Medtronic, Inc.
Cardiovascular · 83d
Cleared Jun 07, 2012
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
K120841 · MBI
Kfx Medical
Orthopedic · 79d
Cleared Jun 07, 2012
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · JDW
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Jun 07, 2012
VIEWFLEX XTRA ICE CATHETER
K121381 · IYO
St Jude Medical
Radiology · 30d
Cleared Jun 07, 2012
FLAT PANEL DETECTOR
K121444 · OWB
Canon, Inc. - Medical Equpment Group
Radiology · 23d
Cleared Jun 06, 2012
MILLENIUM ANTI-SNORING DEVICE
K112627 · LQZ
Millenium Dental Laboratory, Inc.
Dental · 271d
Cleared Jun 06, 2012
ANGIOJET SOLENT DISTA THROMBECTOMY SET
K113363 · QEZ
Medrad, Inc.
Cardiovascular · 204d
Cleared Jun 06, 2012
ADHERENT VISUAL STIMULATOR GOGGLES
K113785 · GWE
Anschel Technology, Inc.
Neurology · 166d
Cleared Jun 06, 2012
LOCATOR OVERDENTURE IMPLANT SYSTEM
K120198 · DZE
Zest Anchors, LLC
Dental · 135d
Cleared Jun 06, 2012
ADAPTAIN SOLUBLE IMPLANT MATERIAL
K120220 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 133d
Cleared Jun 06, 2012
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
K120552 · LFD
Biocosmetics Laboratories
Dental · 104d
Cleared Jun 06, 2012
FORA COMFORTSCAN EAR THERMOMETER
K120712 · FLL
Taidoc Technology Corporation
General Hospital · 90d
Cleared Jun 06, 2012
TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
K120731 · JAQ
Varian Medical Systems, Inc.
Radiology · 89d
Cleared Jun 06, 2012
ZIRCONIA BLANKS (ZIRCOSTAR)
K120852 · EIH
Kerox, Ltd.
Dental · 77d
Cleared Jun 06, 2012
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
K120987 · DWF
Medtronic, Inc.
Cardiovascular · 65d