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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
51169–51192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2010
GLIDER PTA BALLOON CATHETER
K094019 · DQY
Trireme Medical, Inc.
Cardiovascular · 45d
Cleared Feb 12, 2010
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
K100061 · KWQ
K2m, Inc.
Orthopedic · 32d
Cleared Feb 12, 2010
MODIFIED STRAIGHT FIRE LASER FIBER
K100078 · GEX
Boston Scientific Corp
General & Plastic Surgery · 31d
Cleared Feb 12, 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122 · MNH
Spine Wave, Inc.
Orthopedic · 28d
Cleared Feb 12, 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
K100207 · HKI
Topcon Corp.
Ophthalmic · 18d
Cleared Feb 11, 2010
ELECTRO-LIGHT THERAPY
K090250 · ILY
Hill Laboratories Co.
Physical Medicine · 374d
Cleared Feb 09, 2010
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
K093379 · KDI
Bl Healthcare, Inc.
Gastroenterology & Urology · 103d
Cleared Feb 09, 2010
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300,...
K093637 · FIE
Jms North America Corp.
Gastroenterology & Urology · 77d
Cleared Feb 05, 2010
HEMOSIL D-DIMER HS 500, CONTROLS
K090264 · DAP
Instrumentation Laboratory CO
Hematology · 367d
Cleared Feb 05, 2010
ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT
K091210 · MED
Best Sanitizers, Inc.
General Hospital · 287d
Cleared Feb 05, 2010
ORTHO SELECT BONE PLATES AND SCREW SYSTEM
K091493 · HRS
Ortho Select Implant Technology...
Orthopedic · 261d
Cleared Feb 05, 2010
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
K091757 · NUH
Well-Life Healthcare Limited
Neurology · 234d
Cleared Feb 05, 2010
TRUST DAM
K091769 · MSC
Line One Laboratories, Inc.
Obstetrics & Gynecology · 234d
Cleared Feb 05, 2010
SPORT-ELEC BODY CONTROL SYSTEM BS
K092142 · NGX
Sport-Elec
Physical Medicine · 205d
Cleared Feb 05, 2010
FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING...
K093005 · NBW
Taidoc Technology Corporation
Chemistry · 130d
Cleared Feb 05, 2010
ENTELLUS MEDICAL BALLOON DEVICE
K093007 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 130d
Cleared Feb 05, 2010
POCKET BVM
K093081 · BTM
Microbvm Systems , Ltd.
Anesthesiology · 127d
Cleared Feb 05, 2010
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
K093154 · LKD
Radiometer Medical Aps
Anesthesiology · 122d
Cleared Feb 05, 2010
AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120,...
K093476 · DQY
Aga Medical Corp.
Cardiovascular · 88d
Cleared Feb 05, 2010
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM
K093567 · JWH
Anova Implant Solutions, LLC
Orthopedic · 79d
Cleared Feb 05, 2010
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
K093861 · LKM
Iris International, Inc.
Pathology · 51d
Cleared Feb 04, 2010
CORIN METAFIX FEMORAL STEM
K082525 · LZO
Corin USA
Orthopedic · 520d
Cleared Feb 04, 2010
OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
K090609 · NBW
Ok Biotech Co., Ltd.
Chemistry · 335d
Cleared Feb 04, 2010
OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
K091077 · DTK
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 296d