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
146809–146832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1985
H-H BURR HOLE CATHETER SUPPORT
K853367 · GXR
Holter-Hausner Intl.
Neurology · 21d
Cleared Sep 11, 1985
H-H FIXATION & JOINING CONNECTORS
K853369 · JXG
Holter-Hausner Intl.
Neurology · 30d
Cleared Sep 11, 1985
TRAUMA TABLE
K853535 · GDC
Xre Corp.
General & Plastic Surgery · 19d
Cleared Sep 11, 1985
STERILE BIOPSY NEEDLES
K853559
Plasmedics, Inc.
General & Plastic Surgery · 16d
Cleared Sep 11, 1985
DIALYZER, CAPILLARY, HOLLOW FIBER
K853591 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 15d
Cleared Sep 10, 1985
MARLIN SOFT LENS TWEEZER
K850983 · KYE
Marlin Industries
Ophthalmic · 183d
Cleared Sep 10, 1985
MARLIN SOFT LENS HANDLER
K850984 · KYE
Marlin Industries
Ophthalmic · 183d
Cleared Sep 10, 1985
MEDIPART LUNG AEROSOL KIT MP-1012A
K851198 · IYT
Medipart Jerry Alexander
Radiology · 168d
Cleared Sep 10, 1985
MEDIPART LUNG AEROSOL KIT MP-1012A-M
K851199 · IYT
Medipart Jerry Alexander
Radiology · 168d
Cleared Sep 10, 1985
MEDIPART LUNG AEROSOL KIT MP-1024A
K851200 · IYT
Medipart Jerry Alexander
Radiology · 168d
Cleared Sep 10, 1985
MEDIPART LUND AEROSOL KIT MP-1024A-M
K851201 · IYT
Medipart Jerry Alexander
Radiology · 168d
Cleared Sep 10, 1985
RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT
K852749 · FKQ
Mesa Medical, Inc.
Gastroenterology & Urology · 75d
Cleared Sep 10, 1985
LIFE LINC PATIENT CABLE
K853452 · BZQ
Tronomed, Inc.
Anesthesiology · 25d
Cleared Sep 09, 1985
BENTLEY-TRANTEC DISPOS. DOMES D-260-
K841811 · DRS
American Bentley
Cardiovascular · 496d
Cleared Sep 09, 1985
COPAL DIGITAL SPHYGMOMANOMETER UA-560
K851223 · DXN
Takeda Medical, Inc.
Cardiovascular · 167d
Cleared Sep 09, 1985
REMOTE CONTROL MODULE
K851643 · DPS
Circadian, Inc.
Cardiovascular · 143d
Cleared Sep 06, 1985
D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB
K844184 · IYO
D.R.G.
Radiology · 315d
Cleared Sep 06, 1985
COMBIBAG MANUAL RESUSCITATOR
K851171 · BTM
Frontline Medical Corp.
Anesthesiology · 168d
Cleared Sep 06, 1985
NON/GEL ADHESIVE DISPERSIVE ELECTRODE 3427,33-4270
K851304 · GEI
Richards Medical Co., Inc.
General & Plastic Surgery · 158d
Cleared Sep 06, 1985
NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,
K851305 · GEI
Richards Medical Co., Inc.
General & Plastic Surgery · 158d
Cleared Sep 06, 1985
MERIVAARA OBSTETRIC CHAIR/BED MODEL 358
K852174 · KNC
Daun International, Inc.
Obstetrics & Gynecology · 109d
Cleared Sep 06, 1985
PATIENT DATA SYSTEMS CVA
K852175 · BSZ
Patient Data Systems
Anesthesiology · 109d
Cleared Sep 06, 1985
BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420
K852721 · HCZ
The Huxley Instrument Corp.
Obstetrics & Gynecology · 72d
Cleared Sep 06, 1985
FILTRAL HEMODIALYZER
K852885 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 59d