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
122761–122784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 30, 1991
PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE
K904947 · BZG
Planmeca USA, Inc.
Anesthesiology · 90d
Cleared Jan 30, 1991
PM2002 CC AND PM2002 EC
K904948 · EIA
Planmeca USA, Inc.
Dental · 90d
Cleared Jan 30, 1991
MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY
K904983 · EZN
Meadox Surgimed, Inc.
Gastroenterology & Urology · 89d
Cleared Jan 30, 1991
ACE 3.5MM CORTICAL BONE SCREW
K905048 · HWC
Ace Medical Co.
Orthopedic · 83d
Cleared Jan 30, 1991
LATEX GLOVE APPLICATION AND REMOVAL SYSTEM
K905127 · FMC
Success Builders Intl., Inc.
General Hospital · 77d
Cleared Jan 30, 1991
STAT(TM) GLOVE
K905177 · LZC
Success Builders Intl., Inc.
General Hospital · 72d
Cleared Jan 30, 1991
BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)
K905189 · DQI
Baxter Healthcare Corp
General Hospital · 72d
Cleared Jan 30, 1991
TOTAL HIP FEMORAL COMPONENT
K905260 · LZO
Intermedics Orthopedics
Orthopedic · 70d
Cleared Jan 30, 1991
ADULT STAR, MODIFICATION
K905272 · CBK
Infrasonics Corp.
Anesthesiology · 68d
Cleared Jan 30, 1991
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K905432 · DQX
Datascope Corp.
Cardiovascular · 57d
Cleared Jan 30, 1991
MERISTAR-MP
K905493 · GSA
Meridian Diagnostics, Inc.
Microbiology · 54d
Cleared Jan 30, 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540 · BZD
Respironics, Inc.
Anesthesiology · 50d
Cleared Jan 30, 1991
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
K905649 · JQB
Biochemical Trade, Inc.
Chemistry · 43d
Cleared Jan 30, 1991
LEAD STYLET
K905674 · DRB
Cardiac Pacemakers, Inc.
Cardiovascular · 43d