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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
68521–68544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2004
MACROPORE HYDROSORB SPINE SYSTEM
K041105 · KWQ
Macropore Biosurgery, Inc.
Orthopedic · 89d
Cleared Jul 28, 2004
ARTHROJET XT
K041233 · HRX
Hydrocision, Inc.
Orthopedic · 79d
Cleared Jul 28, 2004
RESORBABLE INTERFERENCE SCREW
K041274 · HWC
Arthrotek, Inc.
Orthopedic · 77d
Cleared Jul 28, 2004
GUIDANT MICROWAVE ABLATION SYSTEM
K041340 · NEY
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 69d
Cleared Jul 28, 2004
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
K041399 · FMI
Smiths Medical Asd, Inc.
General Hospital · 63d
Cleared Jul 28, 2004
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
K041410 · FPA
Icu Medical, Inc.
General Hospital · 62d
Cleared Jul 28, 2004
DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES
K041772 · MHX
Datex-Ohmeda
Cardiovascular · 27d
Cleared Jul 28, 2004
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · IZL
General Electric Co.
Radiology · 12d
Cleared Jul 27, 2004
REPROCESSED SURGICAL SCISSORS AND GRASPERS
K033592 · GEI
Clearmedical, Inc.
General & Plastic Surgery · 257d
Cleared Jul 27, 2004
CYTO-CHEX BCT
K040107 · JKA
Streck Laboratories, Inc.
Hematology · 189d
Cleared Jul 27, 2004
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
K040560 · NGZ
Ab Biodisk
Microbiology · 146d
Cleared Jul 27, 2004
DUREPAIR DURA REGENERATION MATRIX
K041000 · GXQ
Medtronic Neurosurgery
Neurology · 99d
Cleared Jul 27, 2004
ACNELIFT
K041103 · GEX
Inner Act, LLC
General & Plastic Surgery · 91d
Cleared Jul 27, 2004
JMS ABSORBABLE ANCHOR AND APPLICATOR
K041159 · GDW
Jms, Inc.
General & Plastic Surgery · 85d
Cleared Jul 27, 2004
ORTHO-CMS
K041162 · LLZ
Medis Medical Imaging Systems BV
Radiology · 85d
Cleared Jul 27, 2004
MEDCOMMONS OPEN RADIOLOGY GATEWAY
K041326 · LLZ
Medcommons, Inc.
Radiology · 70d
Cleared Jul 27, 2004
SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR
K041328 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 69d
Cleared Jul 27, 2004
AOC BONE WAX
K041363 · MTJ
Ceremed , Inc.
General & Plastic Surgery · 67d
Cleared Jul 27, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE...
K041534 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 49d
Cleared Jul 27, 2004
COBRA ADHERE SURGICAL SYSTEM
K041599 · GEI
Estech, Inc.
General & Plastic Surgery · 43d
Cleared Jul 27, 2004
QWIKCHECK-BEADS
K041600 · NRF
Medical Electronics Systems , Ltd.
Hematology · 43d
Cleared Jul 27, 2004
CAAS MRV
K041682 · LLZ
Pie Medical Imaging BV
Radiology · 36d
Cleared Jul 27, 2004
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND...
K041812 · JJY
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 27, 2004
N APOLIPOPROTEIN STANDARD SERUM
K041870 · JIX
Dade Behring, Inc.
Chemistry · 18d