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
51553–51576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2009
LIFE SPINE STAND-ALONE SPACER SYSTEM
K091301 · OVD
Life Spine
Orthopedic · 225d
Cleared Dec 15, 2009
SPECTRA MEDICAL SAFETY SCAPEL
K091462 · GDZ
Spectra, Inc.
General & Plastic Surgery · 211d
Cleared Dec 15, 2009
LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION,...
K091675 · ILY
Reimers and Janssen GmbH
Physical Medicine · 189d
Cleared Dec 15, 2009
ORTHOCOR KNEE SYSTEM BASIC
K091996 · ILX
Orthocor Medical
Physical Medicine · 166d
Cleared Dec 15, 2009
CHIROPRO L SYSTEM
K092214 · EBW
Bien-Air Dental, SA
Dental · 146d
Cleared Dec 15, 2009
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K092325 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 133d
Cleared Dec 15, 2009
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
K092548 · KYI
Extremity Medical, LLC
Orthopedic · 118d
Cleared Dec 15, 2009
TIGRT IVS
K092550 · IYE
Linatech, LLC
Radiology · 118d
Cleared Dec 15, 2009
STRAUMANN DENTAL ABUTMENTS
K092814 · NHA
Straumann Manufacturing, Inc.
Dental · 92d
Cleared Dec 15, 2009
ENDOFLIP
K092850 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 15, 2009
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
K093056 · NPJ
Smith & Nephew, Inc.
Orthopedic · 76d
Cleared Dec 15, 2009
INTEGRA TOTAL WRIST FUSION SYSTEM
K093163 · HRS
Integra LifeSciences Corporation
Orthopedic · 70d
Cleared Dec 15, 2009
3.25 SPLINE TWIST IMPLANT, HA COATED
K093164 · DZE
Zimmer Dental, Inc.
Dental · 70d
Cleared Dec 15, 2009
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K093228 · MBI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Dec 15, 2009
BD GENEOHM MRSA ACP ASSAY
K093346 · NQX
Bd Diagnostics (Geneohm Sciences, Inc.)
Microbiology · 50d
Cleared Dec 15, 2009
ARIA RADIATION ONCOLOGY WITH MIRS
K093527 · IYE
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Dec 15, 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · DQK
St Jude Medical
Cardiovascular · 26d
Cleared Dec 15, 2009
ENDO SMARTCAP
K093665 · FAJ
Byrne Medical, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 14, 2009
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
K090940 · JJT
Astoria-Pacific, Inc.
Chemistry · 255d
Cleared Dec 14, 2009
ELI 350 ELECTROCARDIOGRAPH
K092663 · DPS
Mortara Instrument, Inc.
Cardiovascular · 105d
Cleared Dec 14, 2009
LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
K093498 · JJX
DiaSorin, Inc.
Chemistry · 32d
Cleared Dec 11, 2009
MODIFICATION TO MAMMAPRINT
K081092 · NYI
Agendia
Pathology · 603d
Cleared Dec 11, 2009
GAMMALOC SYSTEM, MODEL 03-00001
K082588 · IYX
Dilon Technologies, LLC
Radiology · 459d
Cleared Dec 11, 2009
XTAG CF60 KIT V2
K083845 · NUA
Luminex Molecular Diagnostics, Inc.
Pathology · 352d