FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123337–123360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 1991
IODOSORB GEL
K905069 · KOZ
Perstorp AB C/O Robert Joel Slomoff
General & Plastic Surgery · 83d
Cleared Jan 31, 1991
MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER
K905080 · LFJ
Kendall Healthcare Products Co....
Gastroenterology & Urology · 79d
Cleared Jan 31, 1991
PEGASUS WITH ACCESSORIES
K905082 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 79d
Cleared Jan 31, 1991
JAIN SUTURE/VESIBAND ORGANIZER
K905105 · MDM
Jain Surgical Equipment, Inc.
General & Plastic Surgery · 79d
Cleared Jan 31, 1991
AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER
K905106 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 79d
Cleared Jan 31, 1991
FLOWERS CHIN IMPLANT
K905267 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 71d
Cleared Jan 31, 1991
FLOWERS JOWL IMPLANT
K905268 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 71d
Cleared Jan 31, 1991
UST-969-5 CONVEX TRANSDUCER
K905391 · ITX
Ge Medical Systems Information...
Radiology · 62d
Cleared Jan 31, 1991
ELMED PNEUMOMAT DIGITAL
K905417 · HIF
Elmed, Inc.
Obstetrics & Gynecology · 58d
Cleared Jan 31, 1991
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
K905440 · GAS
United States Surgical, A Division of...
General & Plastic Surgery · 58d
Cleared Jan 31, 1991
UBI MAGIWEL CORTISOL QUANTITATIVE
K905473 · CGR
United Biotech, Inc.
Chemistry · 56d
Cleared Jan 31, 1991
KINETIC AMYLASE DETERMINATION
K905651 · JFJ
Biochemical Trade, Inc.
Chemistry · 44d
Cleared Jan 31, 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
K905661 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Jan 31, 1991
FLEXIBLE ENDOSCOPIC ELECTRODE
K905731 · FAS
Applied Urology, Inc.
Gastroenterology & Urology · 38d
Cleared Jan 31, 1991
IMMULITE HS-TSH
K905769 · JLW
Cirrus Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 31, 1991
INTRAUTERINE CATHETER SET
K905812 · HGS
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 34d
Cleared Jan 31, 1991
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029 · DXK
Spacelabs, Inc.
Cardiovascular · 28d
Cleared Jan 30, 1991
FUKUDA DENSHI MODEL LX-3100
K903514 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 180d
Cleared Jan 30, 1991
PHILIPS MULTILEAF COLLIMATOR (MLC)
K904124 · IXI
Philips Medical Systems, Inc.
Radiology · 146d
Cleared Jan 30, 1991
MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER
K904409 · GZF
Medtronic Vascular
Neurology · 126d
Cleared Jan 30, 1991
MODEL #250 DEFIB CABLE
K904466 · LDD
Cardiotronics, Inc.
Cardiovascular · 121d
Cleared Jan 30, 1991
LU-TEX II
K904535 · GAS
Lukens Medical Corp.
General & Plastic Surgery · 118d
Cleared Jan 30, 1991
DANNIFLEX MODEL 500TM CPM
K904735 · BXB
Buckman Co., Inc.
Physical Medicine · 105d
Cleared Jan 30, 1991
FLEXERCYCLE
K904823 · ISD
Medmetric Corp.
Physical Medicine · 97d