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
63121–63144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2006
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
K053520 · NQN
Tripath Imaging, Inc.
Pathology · 113d
Cleared Apr 11, 2006
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
K060302 · KNQ
Cordis Europa, N.V.
Gastroenterology & Urology · 64d
Cleared Apr 11, 2006
SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
K060522 · MAI
Scandius Biomedical, Inc.
Orthopedic · 43d
Cleared Apr 11, 2006
HDR 1000 PLUS WELL CHAMBER, MODEL 90008
K060532 · JAQ
Standard Imaging, Inc.
Radiology · 42d
Cleared Apr 11, 2006
VUMAX
K060626 · IYO
Sonomed, Inc.
Radiology · 33d
Cleared Apr 11, 2006
ATRILAZE SURGICAL ABLATION SYSTEM
K060680 · GEX
Medical Cv, Inc.
General & Plastic Surgery · 27d
Cleared Apr 11, 2006
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K060695 · LHN
Ion Beam Applications S.A.
Radiology · 26d
Cleared Apr 11, 2006
TRAVEL PAL (MM-111B) /MEGA MOTION
K060697 · INI
Mega Motion, Inc.
Physical Medicine · 26d
Cleared Apr 10, 2006
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
K050826 · HGM
Cetro America
Obstetrics & Gynecology · 374d
Cleared Apr 10, 2006
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190,...
K051984 · NFA
Boston Scientific Corp
Cardiovascular · 262d
Cleared Apr 10, 2006
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
K052322 · FTM
C.R. Bard, Inc.
General & Plastic Surgery · 228d
Cleared Apr 10, 2006
EZ-OX PLUS
K053117 · ECX
Air Liquide Healthcare America
Anesthesiology · 154d
Cleared Apr 10, 2006
BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
K053441 · KGO
Regent Medical Americas, LLC
General Hospital · 122d
Cleared Apr 10, 2006
SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
K053542 · HAW
Praxim S.A
Neurology · 111d
Cleared Apr 10, 2006
STETHOFLUX
K060064 · JAF
Odvi
Radiology · 91d
Cleared Apr 10, 2006
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
K060193 · BSZ
Oceanic Medical Products, Inc.
Anesthesiology · 75d
Cleared Apr 10, 2006
MICROPOWER HAND PIECE HIGH SPEED DRILL
K060260 · HBC
Linvatec Corp.
Neurology · 68d
Cleared Apr 10, 2006
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
K060270 · DZI
Linvatec Corp.
Dental · 68d
Cleared Apr 10, 2006
TOTAL KNEE SURGETICS NAVIGATION SYSTEM
K060282 · HAW
Praxim S.A
Neurology · 66d
Cleared Apr 10, 2006
INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
K060391 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 54d
Cleared Apr 10, 2006
ECHOHEART TRANSVAGINAL DOPPLER PROBE
K060410 · HEK
Summit Doppler Systems, Inc.
Radiology · 53d
Cleared Apr 10, 2006
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
K060658 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 54d
Cleared Apr 10, 2006
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
K060755 · CDD
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Apr 10, 2006
ARTHROCARE WANDS
K060823 · GEI
Arthrocare Corp.
General & Plastic Surgery · 14d