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
165985–166008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1980
HELFET ELBOW PROSTHESIS
K802460 · JDB
Depuy, Inc.
Orthopedic · 42d
Cleared Nov 19, 1980
CARDIACINDEX COMPUTER MODEL SP 1435
K802476 · DXG
Gould, Inc.
Cardiovascular · 41d
Cleared Nov 19, 1980
REIGNING DENTURE
K802490 · EBI
Oki Shiks USA , Ltd.
Dental · 40d
Cleared Nov 19, 1980
MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.
K802588 · DXY
Arco Medical Products Co.
Cardiovascular · 30d
Cleared Nov 19, 1980
CARBIDE CUTTING INSTRUMENT/INTRAARTICU
K802598 · HTT
The Anspach Effort, Inc.
Orthopedic · 29d
Cleared Nov 19, 1980
TERPERATUR SENSING DEVICE
K802607 · FLL
Burditt & Calkins-Siemens-Elema
General Hospital · 29d
Cleared Nov 19, 1980
ENDOTRACHEAL TUBE HOLDER
K802675 · JAY
Respiratory Support Products, Inc.
Anesthesiology · 21d
Cleared Nov 19, 1980
FMS-02 FLOOR-UNIT MODEL MICROSCOPE
K802713 · FSO
Jedmed Instrument Co.
General & Plastic Surgery · 19d
Cleared Nov 19, 1980
EXTERNAL FIXATION SYSTEM
K802722 · JEC
Howmedica Corp.
Orthopedic · 19d
Cleared Nov 19, 1980
EXTENDED BALLJOINT GRIP
K802723 · JEC
Howmedica Corp.
Orthopedic · 19d
Cleared Nov 19, 1980
INSTRUMENTS NONSTERILE & STERILE
K802726 · HAO
Ascep, Inc.
Neurology · 23d
Cleared Nov 19, 1980
FOLDING ROLL-ABOUT CHAIR
K802744 · INM
Winco Winfield Co., Inc.
Physical Medicine · 16d
Cleared Nov 19, 1980
FOLDING SHOWER-COMMODE CHAIR
K802745 · INM
Winco Winfield Co., Inc.
Physical Medicine · 16d
Cleared Nov 19, 1980
LATEX PENROSE TUBING CAT. #20400,414,416
K802761 · GAZ
American Hospital Supply Corp.
General Hospital · 15d
Cleared Nov 19, 1980
HOFFMAN LEG LENGTHENING DEVICE
K802776 · JEC
Howmedica Corp.
Orthopedic · 14d
Cleared Nov 19, 1980
THE CRITERION II PACING SYS. MONITOR
K802782 · DRT
Dart Medical Equipment
Cardiovascular · 16d
Cleared Nov 19, 1980
CONVALESCENT RECLINER
K802803 · INO
Winfield Co., Inc.
Physical Medicine · 16d
Cleared Nov 18, 1980
CAVITRON ULTRASONIC SURG. ASPIR. CUSA
K801623 · LFL
Cavitron Corp.
General & Plastic Surgery · 126d
Cleared Nov 18, 1980
IC-2 VENTILATOR
K801890 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 102d
Cleared Nov 17, 1980
SHARPS CADDY MAGNETIC & SHARPS CADDY FOA
K802866 · KDC
Instranetics, Inc.
General & Plastic Surgery · 5d
Cleared Nov 14, 1980
SILENTSLEEP
K801927 · DYN
Slumber Research, Inc.
Dental · 94d
Cleared Nov 14, 1980
A.M.P.C.O. SKIN SCRUB TRAY
K802570 · FSM
Associated Medical Products Co.
General & Plastic Surgery · 28d
Cleared Nov 13, 1980
MEDTRONIC MODEL 6958
K800870 · DTB
Medtronic Vascular
Cardiovascular · 210d
Cleared Nov 13, 1980
WORRELL PATELLA FEMORAL SHIELD
K801934
Depuy, Inc.
Orthopedic · 93d