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
151681–151704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · BTO
Shiley, Inc.
Anesthesiology · 25d
Cleared Oct 19, 1984
THERMAL GRAYSCALE RF-100
K843836 · DSF
Fukuda Denshi USA, Inc.
Cardiovascular · 18d
Cleared Oct 18, 1984
PEDIATRIC DIAG. CRITERIA OPTION 5600C
K841416 · DSI
Hewlett-Packard Co.
Cardiovascular · 196d
Cleared Oct 18, 1984
AMER. BENTLEY CONTINU-BLOOD PROCESSOR-
K841585 · KDI
American Bentley
Gastroenterology & Urology · 184d
Cleared Oct 18, 1984
ELECTRODE CATHETER, ORTHOGONAL TYPE
K841802 · LDF
Webster Laboratories, Inc.
Cardiovascular · 170d
Cleared Oct 18, 1984
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE
K842481 · LYK
American Edwards Laboratories
Cardiovascular · 115d
Cleared Oct 18, 1984
SPACELABS ALPHA PC PATIENT COMPUTER
K842616 · DSI
Spacelabs, Inc.
Cardiovascular · 105d
Cleared Oct 18, 1984
LIFEPAK 8
K842624 · LDD
Physio-Control Corp.
Cardiovascular · 105d
Cleared Oct 18, 1984
INFRARED COAGULATOR
K842810 · KNS
Endo Lase, Inc.
Gastroenterology & Urology · 92d
Cleared Oct 18, 1984
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
K842829 · DTL
North American Instrument Corp.
Cardiovascular · 90d
Cleared Oct 18, 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K842885 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 87d
Cleared Oct 18, 1984
EMA FREEGENOL DENTAL CEMENT
K842994 · EMA
Int'L Corp.
Dental · 80d
Cleared Oct 18, 1984
FRESENIUS HAEMODIALYSIS A2008
K843014 · KDI
Seratronics, Inc.
Hematology · 79d
Cleared Oct 18, 1984
TWO COMPONENT RTV VINYL SILICONE MATER
K843145 · ELW
Crown Delta Corp.
Dental · 69d
Cleared Oct 18, 1984
LIFEPAK 200
K843229 · LDD
Physio-Control Corp.
Cardiovascular · 62d
Cleared Oct 18, 1984
ARRHYTHMIA CENTRAL OCC-7101
K843287 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Oct 18, 1984
FLOW-DIRECTED THERMODILUTION CATH
K843409 · DYG
Andover Medical, Inc.
Cardiovascular · 48d
Cleared Oct 18, 1984
THERMAL DILUTION CATHETER
K843411 · DYG
Andover Medical, Inc.
Cardiovascular · 48d
Cleared Oct 18, 1984
ARGYLE SILICONE LEFT VENTRICULAR AND
K843444 · DWF
Sherwood Medical Co.
Cardiovascular · 43d
Cleared Oct 18, 1984
PHARMA-PLAST CONNECTING TUBE TYPE URIN-
K843481 · KNX
Zimmar Consulting , Ltd.
Gastroenterology & Urology · 42d
Cleared Oct 18, 1984
FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN
K843500 · DYB
Cardio-Vascular Innovations, Inc.
Cardiovascular · 42d
Cleared Oct 18, 1984
AMER. BENTLEY HEMOFILTER HOLDER HFH-1
K843504 · FKI
American Bentley
Gastroenterology & Urology · 42d
Cleared Oct 18, 1984
ORTHOMITE 111 ADHESIVE
K843527 · DYH
Rocky Mountain Orthodontics, Inc.
Dental · 41d
Cleared Oct 18, 1984
PO 2 LYTRODE
K843538 · DRY
Polystan C/O Vitalcor, Inc.
Cardiovascular · 41d