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
72529–72552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2003
PRESSURE WIRE SENSOR, MODELS 12004/12304
K031662 · DXO
Radi Medical Systems AB
Cardiovascular · 9d
Cleared Jun 05, 2003
MERDOC SYSTEM
K022393 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 317d
Cleared Jun 05, 2003
EZMANAGER PLUS
K022394 · LZG
Animas Corp.
General Hospital · 317d
Cleared Jun 05, 2003
PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES
K030444 · KGO
Primus Gloves Private , Ltd.
General Hospital · 114d
Cleared Jun 05, 2003
POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING...
K030445 · KGO
Primus Gloves Private , Ltd.
General Hospital · 114d
Cleared Jun 05, 2003
C-PORT
K030636 · LJT
Clinisurg Vascular Products, LLC
General Hospital · 97d
Cleared Jun 05, 2003
SCB COMPUTER MOTION INTERFACE CONTROLLER
K030718 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 90d
Cleared Jun 05, 2003
POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT
K030727 · EMA
Healex Products, Inc.
Dental · 90d
Cleared Jun 05, 2003
PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US
K031470 · BZD
Tyco Healthcare Nancy
Anesthesiology · 27d
Cleared Jun 05, 2003
MODIFICATION TO CAVERMAP SURGICAL AID
K031527 · FGM
Blue Torch Medical Technologies
Gastroenterology & Urology · 21d
Cleared Jun 04, 2003
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
K023691 · NFA
Boston Scientific Epi
Cardiovascular · 215d
Cleared Jun 04, 2003
SHELHIGH BIORING
K023940 · KRH
Shelhigh, Inc.
Cardiovascular · 190d
Cleared Jun 04, 2003
PALOMAR LIGHTCUBE
K024179 · ILY
Palomar Medical Products, Inc.
Physical Medicine · 168d
Cleared Jun 04, 2003
CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT
K030700 · GEX
Biolitec, Inc.
General & Plastic Surgery · 90d
Cleared Jun 04, 2003
BIO-MODULAR SHOULDER SYSTEM
K030710 · KWT
Biomet, Inc.
Orthopedic · 90d
Cleared Jun 04, 2003
LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112
K030824 · GCJ
Hakko Medical Co., Ltd.
General & Plastic Surgery · 82d
Cleared Jun 04, 2003
3-CCD DIGITAL CAMERA SYSTEM
K031098 · GCJ
Linvatec Corp.
General & Plastic Surgery · 58d
Cleared Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · JXG
Aesculap, Inc.
Neurology · 41d
Cleared Jun 04, 2003
CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER
K031488 · GEX
Cynosure, Inc.
General & Plastic Surgery · 23d
Cleared Jun 03, 2003
SHANCHUAN SYRINGE
K021993 · FMF
Shangdong Zibo Shanchuan Medical...
General Hospital · 350d
Cleared Jun 03, 2003
MAGLIFE C/MAGLIFE C PLUS
K023195 · MWI
Schiller Medical S.A.
Cardiovascular · 251d
Cleared Jun 03, 2003
ARTERIALFLOW SYSTEM, MODEL 32A
K024019 · JOW
Aircast, Inc.
Cardiovascular · 180d
Cleared Jun 03, 2003
PNEUTON VENTILATOR
K024344 · CBK
Airon Corporation
Anesthesiology · 158d
Cleared Jun 03, 2003
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 95d