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

Filters: Cleared only ×
176,076 results
66481–66504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2005
OMNILUX PLUS
K043317 · ILY
Photo Therapeutics Limited
Physical Medicine · 103d
Cleared Mar 15, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML
K043458 · LON
Becton, Dickinson & CO
Microbiology · 90d
Cleared Mar 15, 2005
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
K050112 · KPL
Prime Pacific Health Innovations...
Gastroenterology & Urology · 56d
Cleared Mar 15, 2005
CELLTRACKA ANALYZER II
K050145 · NQI
Immunicon Corp.
Pathology · 50d
Cleared Mar 15, 2005
CEDIA TACROLIMUS ASSAY
K050206 · MLM
Microgenics Corp.
Toxicology · 46d
Cleared Mar 15, 2005
CELLSEARCH CIRCULATING TUMOR CELL KIT
K050245 · NQI
Veridex, LLC
Pathology · 41d
Cleared Mar 15, 2005
VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)
K050362 · EIH
Vident
Dental · 29d
Cleared Mar 15, 2005
SYNTHES MANDIBLE EXTERNAL FIXATOR
K050378 · MQN
Synthes (Usa)
Dental · 28d
Cleared Mar 14, 2005
VENTILAIR II MEDICAL AIR COMPRESSOR
K041781 · BTI
Hamilton Medical AG
Anesthesiology · 256d
Cleared Mar 14, 2005
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
K042169 · JJE
Stanbio Laboratory
Chemistry · 215d
Cleared Mar 14, 2005
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
K042515 · JWH
Smith & Nephew, Inc.
Orthopedic · 179d
Cleared Mar 14, 2005
MODEL BMLS03-7
K042711 · GZJ
Biomedical Life Systems, Inc.
Neurology · 165d
Cleared Mar 14, 2005
PINNACLE CONSTRAINED ACETABULAR LINERS
K043058 · KWZ
Depuy, Inc.
Orthopedic · 129d
Cleared Mar 14, 2005
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
K043144 · LSL
Gen-Probe, Inc.
Microbiology · 119d
Cleared Mar 14, 2005
SOLEUS POWERED WHEELCHAIR, MODEL FAD-2
K043511 · ITI
Soleus Champ International Co., Ltd.
Physical Medicine · 84d
Cleared Mar 14, 2005
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
K043570 · HSX
Conformis, Inc.
Orthopedic · 77d
Cleared Mar 14, 2005
WU'S 4-WHEELED NEO SCOOTER, WT-XL4
K050042 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 66d
Cleared Mar 14, 2005
SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
K050108 · GEX
Innovaquartz
General & Plastic Surgery · 55d
Cleared Mar 14, 2005
AOS HUMERAL NAIL
K050241 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 40d
Cleared Mar 14, 2005
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
K050344 · FZP
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 31d
Cleared Mar 14, 2005
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
K050361 · GEI
Boston Scientific Corp
General & Plastic Surgery · 28d
Cleared Mar 14, 2005
TAMARACK ANTERIOR THORACOLUNBAR
K050390 · KWQ
Alphatec/Nexmed
Orthopedic · 26d
Cleared Mar 14, 2005
VAPORMAX
K050412 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 24d
Cleared Mar 14, 2005
MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM
K050457 · KTT
Merete Medical GmbH
Orthopedic · 19d