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
166777–166800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1980
OPEN-LOOP INSULIN DELIVERY SYSTEM
K801704 · FRN
Delta Medical Industries
General Hospital · 20d
Cleared Aug 13, 1980
BK-6010 CATHETER TUBE HOLDER
K801711 · KNX
Fred Sammons, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 13, 1980
UR 150-UR 150T
K801723 · KQS
Siemens Corp.
Radiology · 20d
Cleared Aug 13, 1980
KANGAROO ENTERAL FEEDING PUMP
K801725 · FRN
Chesebrough-Pond'S U.S.A. Co.
General Hospital · 20d
Cleared Aug 13, 1980
KRYMED SYSTEM 4001 TILT SCOPE
K801730 · HEX
Cryomedics, Inc.
Obstetrics & Gynecology · 19d
Cleared Aug 13, 1980
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K801731 · KDI
Cordis Corp.
Gastroenterology & Urology · 19d
Cleared Aug 13, 1980
NOBLE MEDEL ENT TREATMENT UNIT
K801738 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
NOBLE MODEL DOUBLESIDED TREATMENT UNIT
K801739 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
TREATMENT UNIT FOR DOCTOR'S ROUNDS
K801740 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
PRETTY MODEL ENT TREATMENT UNIT
K801741 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
NEW FINE MODEL ENT TREATMENT UNIT
K801742 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
TERUMO FETAL MONITOR # FHM-602
K801747 · HGM
Terumo Medical Corp.
Obstetrics & Gynecology · 16d
Cleared Aug 13, 1980
MMI/GAELTEC CATHETER TIP PRESSURE
K801755 · GWM
Medical Measurements, Inc.
Neurology · 16d
Cleared Aug 13, 1980
IONESCU-SHILEY PERICARDIAL PATCH
K801764 · DXZ
Shiley, Inc.
Cardiovascular · 16d
Cleared Aug 13, 1980
CATHETER IRRIGATION SYRINGES, #3100,3110
K801781 · KQT
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 16d
Cleared Aug 13, 1980
GENERAL PURPOSE IRRIGATING/ASPIR SYR.
K801782 · KQT
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 16d
Cleared Aug 13, 1980
CATHETER IRRIGATION TRAYS, #3300, 3310 &
K801783 · EYN
The Healthcare Group Laboratories, Inc.
General & Plastic Surgery · 16d
Cleared Aug 13, 1980
URINARY CATHETERS #3400,3410 &3420
K801784 · KOD
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 16d
Cleared Aug 13, 1980
ELASTIC ADHESIVE BANDAGES(STERILE)
K801794 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 15d
Cleared Aug 13, 1980
THE COMFORT LIFT
K801796 · FMR
Gettner Enterprises, Inc.
General Hospital · 15d
Cleared Aug 13, 1980
MAINFLOW BACTERIA FILTER
K801803 · CAH
Omnicon Medical Corp.
General Hospital · 15d
Cleared Aug 13, 1980
ANESTHESIA BACTERIA FILTER
K801804 · CAH
Omnicon Medical Corp.
General Hospital · 15d
Cleared Aug 13, 1980
ORTHODONTIC BRACKET/SPEED/HANSON SPEED
K801809 · EJF
Strite Industries , Ltd.
Dental · 14d
Cleared Aug 13, 1980
FLOW MED 150
K801821 · FPA
D.R.O. Medical, Inc.
General Hospital · 13d