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
36793–36816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2014
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
K141407 · MBH
Biomet, Inc.
Orthopedic · 152d
Cleared Oct 27, 2014
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
K141809 · DRM
Defibtech, LLC
Cardiovascular · 112d
Cleared Oct 27, 2014
FLOSPINE PEDICLE SCREW SYSTEM
K141850 · NKB
Flospine
Orthopedic · 110d
Cleared Oct 27, 2014
ENDOSKELETON
K141953 · MAX
Titan Spine, LLC
Orthopedic · 101d
Cleared Oct 27, 2014
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
K142070 · FTM
Rti Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Oct 27, 2014
Xia® Growth Rod Conversion Set
K142114 · PGM
Stryker Corporation
Orthopedic · 84d
Cleared Oct 27, 2014
Uroflowmeter
K142425 · EXY
Be Technologies, Inc.
Gastroenterology & Urology · 59d
Cleared Oct 27, 2014
CD HORIZON Spinal System
K142847 · NKB
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 27d
Cleared Oct 24, 2014
CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
K133069 · EFB
Codent Technical Industry Co., Ltd.
Dental · 389d
Cleared Oct 24, 2014
E-FIT EF-1280 EMS MACHINE
K133225 · NGX
Fit-Pro Kft , Ltd.
Physical Medicine · 368d
Cleared Oct 24, 2014
NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS...
K140022 · OMP
Cork Medical Products, LLC
General & Plastic Surgery · 294d
Cleared CT Oct 24, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR...
K140647 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 225d
Cleared Oct 24, 2014
CLINPRO PROPHY POWDER
K140684 · PIP
3M Deutschland GmbH
Dental · 220d
Cleared Oct 24, 2014
UNIVERSAL NAVIGATION INSTRUMENTS
K140927 · OLO
Medos International SARL
Orthopedic · 196d
Cleared Oct 24, 2014
RENOVOCATH RC120
K141175 · MJN
Renovorx, Inc.
Cardiovascular · 171d
Cleared Oct 24, 2014
OPTON PRO
K141564 · ILY
Zimmer Medizinsystems GmbH
Physical Medicine · 134d
Cleared Oct 24, 2014
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
K141714 · HTY
Wrightmedicaltechnologyinc
Orthopedic · 121d
Cleared Oct 24, 2014
NEPHROS DSU-H, NEPHROS SSU-H
K141731 · NHV
Nephros, Inc.
Gastroenterology & Urology · 119d
Cleared Oct 24, 2014
OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
K141759 · MMK
Oak Ridge Products, LLC
General Hospital · 115d
Cleared Oct 24, 2014
STALIF CTI, STALIF C
K142079 · OVE
Centinel Spine, Inc.
Orthopedic · 85d
Cleared Oct 24, 2014
ELECYS CMV IGM IMMUNOASSAY
K142133 · LFZ
Roche Diagnostics
Microbiology · 81d
Cleared Oct 24, 2014
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm...
K142574 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 42d
Cleared Oct 24, 2014
CrossCLIP Implant System
K142727 · JDR
Orthodiscovery Group, LLC(D.B.A....
Orthopedic · 31d
Cleared Oct 24, 2014
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
K142784 · DTZ
Medtronic, Inc.
Cardiovascular · 28d