FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165145–165168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 12, 1980
SI-14
K801908 · KDC
Kmi Medical, Inc.
General & Plastic Surgery · 93d
Cleared Nov 12, 1980
TUTTIFRUTTI (NON-PRES. SUNGLASSES)
K801922 · HQY
Safety Plastics of New York
Ophthalmic · 92d
Cleared Nov 12, 1980
ANALYTIC TECH. METAL POINT HEATER #3001
K801974 · ELA
Analytic Technology
Dental · 85d
Cleared Nov 12, 1980
DATASON DB SYSTEM
K801986 · IYO
General Electric Co.
Radiology · 85d
Cleared Nov 12, 1980
OBJECTIVE REFRACTOR
K802029 · HKO
Zeiss Humphrey System
Ophthalmic · 83d
Cleared Nov 12, 1980
TM-5 INTRACRANIAL PRESSURE MONITOR
K802149 · GWM
Nicolet Biomedical Instruments
Neurology · 65d