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
65161–65184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2005
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
K051606 · DTN
Gish Biomedical, Inc.
Cardiovascular · 57d
Cleared Aug 12, 2005
CLEVER TD-3018A BLOOD PRESSURE MONITOR
K051703 · DXN
Taidoc Technology Corporation
Cardiovascular · 49d
Cleared Aug 12, 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
K051748 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 44d
Cleared Aug 12, 2005
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
K051777 · LZA
Hartalega Sdn Bhd
General Hospital · 42d
Cleared Aug 12, 2005
JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS...
K051827 · HRX
Joimax GmbH
Orthopedic · 37d
Cleared Aug 12, 2005
TRIO MONITOR
K051897 · MWI
Datascope Corp.
Cardiovascular · 30d
Cleared Aug 12, 2005
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV...
K051900 · MVN
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 30d
Cleared Aug 12, 2005
ELEKTA SYNERGY
K051932 · IYE
Elekta, Inc.
Radiology · 30d
Cleared Aug 12, 2005
CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE
K052097 · EBF
Dentsply International
Dental · 9d
Cleared Aug 11, 2005
MODIFICATION TO ABL800 FLEX
K050869 · CIG
Radiometer Medical Aps
Chemistry · 127d
Cleared Aug 11, 2005
BIOPLANT
K050984 · LYC
Kerr Dental Materials Center
Dental · 114d
Cleared Aug 11, 2005
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
K051071 · LSR
Viramed Biotech AG
Microbiology · 107d
Cleared Aug 11, 2005
AXIOM NVP8500
K051135 · IPF
Axiom Worldwide, Inc.
Physical Medicine · 100d
Cleared Aug 11, 2005
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
K051169 · LSR
Viramed Biotech AG
Microbiology · 104d
Cleared Aug 11, 2005
OXIMAX NPB-40 HANDHELD PULSE OXIMETER
K051352 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 79d
Cleared Aug 11, 2005
SCB/STERIS OR-LIGHT INTERFACE BOX
K051505 · FTA
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 65d
Cleared Aug 11, 2005
I-STOP
K051533 · OTN
Cl Medical
Gastroenterology & Urology · 63d
Cleared Aug 11, 2005
VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR
K051644 · GEI
Valleylab
General & Plastic Surgery · 52d
Cleared Aug 11, 2005
ORTHOMEND
K051766 · FTL
Tei Biosciences, Inc.
General & Plastic Surgery · 42d
Cleared Aug 11, 2005
SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073,...
K051848 · GDW
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 35d
Cleared Aug 11, 2005
NIO 2MP-21
K051902 · LLZ
Barcoview
Radiology · 29d
Cleared Aug 11, 2005
MODEL SR-115 PORTABLE X-RAY SYSTEM
K052001 · IZL
Source-Ray, Inc.
Radiology · 17d
Cleared Aug 11, 2005
GE OEC ALTITUDE
K052039 · IZI
Ge Oec Medical Systems
Radiology · 14d
Cleared Aug 11, 2005
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
K052100 · FTL
Proxy Biomedical , Ltd.
General & Plastic Surgery · 8d