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
62737–62760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2006
FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL...
K061010 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 41d
Cleared May 23, 2006
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
K061072 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 36d
Cleared May 23, 2006
ORTHOMON
K061113 · GWF
Axon Systems, Inc.
Neurology · 32d
Cleared May 23, 2006
DVTCARE CA5
K061125 · JOW
Doctors Orders
Cardiovascular · 29d
Cleared May 23, 2006
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · KRH
Medtronic Vascular
Cardiovascular · 29d
Cleared May 23, 2006
CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
K061175 · EIA
Sota Precision Optics, Inc.
Dental · 26d
Cleared May 23, 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER...
K061192 · LZA
Ethicon Endo-Surgery, LLC
General Hospital · 25d
Cleared May 23, 2006
TEMPFX ESTHETIC PROVISIONAL SYSTEM
K061264 · EBG
Dentsply International, Inc.
Dental · 18d
Cleared May 23, 2006
7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L
K061273 · IOR
Nova Ortho-Med, Inc.
Physical Medicine · 15d
Cleared May 22, 2006
SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC...
K060530 · ELL
Lifecore Biomedical, Inc.
Dental · 83d
Cleared May 22, 2006
GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000
K060649 · FLL
Tyco Healthcare Group LP
General Hospital · 70d
Cleared May 22, 2006
CRYOSHAPE
K060928 · GEH
Etgar Group H.M.Y.A. , Ltd.
General & Plastic Surgery · 48d
Cleared May 22, 2006
MONDIAL
K060994 · ELM
Heraeus Kulzer, Inc.
Dental · 41d
Cleared May 22, 2006
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
K060995 · MSS
Duckworth & Kent, Ltd.
Ophthalmic · 41d
Cleared May 22, 2006
CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
K061112 · DQA
Conmed Corporation
Anesthesiology · 31d
Cleared May 22, 2006
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
K061128 · FRN
Medrad, Inc.
General Hospital · 28d
Cleared May 22, 2006
FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE...
K061191 · DQA
Measurement Specialties, Inc.
Anesthesiology · 24d
Cleared May 19, 2006
ARGUS, MODEL LCM
K053207 · MHX
Schiller AG
Cardiovascular · 184d
Cleared May 19, 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · DKZ
Dade Behring, Inc.
Chemistry · 169d
Cleared May 19, 2006
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
K053552 · MQL
Intl., Inc.
Obstetrics & Gynecology · 150d
Cleared May 19, 2006
MANI NEEDLE & SUTURE PACK (NYLON)
K053637 · GAR
Mani, Inc.
General & Plastic Surgery · 141d
Cleared May 19, 2006
MANI NEEDLE & SUTURE PACK (SILK)
K053638 · GAP
Mani, Inc.
General & Plastic Surgery · 141d
Cleared May 19, 2006
LEGACY ABUTMENT SYSTEM
K060063 · NHA
Implant Direct, LLC
Dental · 130d
Cleared May 19, 2006
SLEEP SPLINT
K060122 · LRK
Nakagawa Dental Clinic
Dental · 122d