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
140353–140376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1987
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR
K870829 · DTN
3M Health Care, Sarns
Cardiovascular · 64d
Cleared May 06, 1987
LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER
K870886 · LJT
Strato Medical Corp.
General Hospital · 62d
Cleared May 06, 1987
IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM
K870934 · DXG
Integrated Medical Systems, Inc.
Cardiovascular · 58d
Cleared May 06, 1987
ONGUARD 1000, CATALOG #043611-000 & 043611-001
K870976 · DTQ
Cobe Laboratories, Inc.
Cardiovascular · 57d
Cleared May 06, 1987
MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR
K870981 · GEI
Everest Medical Corp.
General & Plastic Surgery · 57d
Cleared May 06, 1987
MVP-1500 CONTINUOUS VENTILATOR
K871009 · CBK
Medimex, Inc.
Anesthesiology · 54d
Cleared May 06, 1987
PRECIMAT(R) CRP
K871055 · DCK
Boehringer Mannheim Corp.
Immunology · 50d
Cleared May 06, 1987
PELTIERTHERAPY(C) HEAT/COLD TREATMENT
K871112 · IMF
Henley Intl.
Physical Medicine · 48d
Cleared May 06, 1987
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
K871196 · DHR
Orion Diagnostica, Inc.
Immunology · 43d
Cleared May 06, 1987
IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL
K871333 · DTB
Medtronic Vascular
Cardiovascular · 33d
Cleared May 06, 1987
NAMIC SELDINGER INTRODUCER NEEDLE
K871378 · DRC
North American Instrument Corp.
Cardiovascular · 29d
Cleared May 06, 1987
NAMIC ONE PART INTRODUCER NEEDLE
K871382 · DRC
North American Instrument Corp.
Cardiovascular · 29d
Cleared May 06, 1987
AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
K871391 · INF
Amigo Sales, Inc.
Physical Medicine · 29d
Cleared May 06, 1987
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52
K871438 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 23d
Cleared May 06, 1987
UPPERCYCLE STATIONARY EXERCISE MACHINES
K871494 · ISD
Engineering Dynamics Corp.
Physical Medicine · 20d
Cleared May 06, 1987
DISPOSABLE PERIODONTAL PROBE
K871504 · EIX
Periodontal Health Brush, Inc.
Dental · 19d
Cleared May 06, 1987
CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II
K871537 · JJY
Canyon Diagnostics, Inc.
Chemistry · 16d
Cleared May 06, 1987
PATIENT MOVER(TM)
K871582 · ILK
T.B.S., Inc.
Physical Medicine · 13d
Cleared May 06, 1987
FOLDING LITTER SUPPORT, NSN6530-00-660-0034
K871629 · FPP
Junkin Safety Appliance Co., Inc.
General Hospital · 9d
Cleared May 04, 1987
AM1000
K864590 · BSZ
Bear Medical Systems, Inc.
Anesthesiology · 164d
Cleared May 04, 1987
PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085
K870692 · HGM
Peritronics Research and Development,...
Obstetrics & Gynecology · 74d
Cleared May 04, 1987
WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM
K870830 · KWP
Warsaw Orthopedic, Inc.
Orthopedic · 62d
Cleared May 04, 1987
NO. 1552, VALVED VENTI-COMP
K870895 · CBP
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 60d
Cleared May 04, 1987
FIAD EXPLOR-X
K871051 · EHD
United States Dental
Radiology · 48d