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
155257–155280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1983
PHYSIOLOGICAL PRESS. MEASUREMENT CATH
K832579 · DXO
Camino Laboratories, Inc.
Cardiovascular · 79d
Cleared Oct 20, 1983
PHYSIOLOGICAL PRESSURE MEASUREMENT CATH
K832604 · DXO
Camino Laboratories, Inc.
Cardiovascular · 78d
Cleared Oct 20, 1983
ULTRA LIGHT RAAF CATHETER
K832784 · DQY
Quinton, Inc.
Cardiovascular · 65d
Cleared Oct 20, 1983
FIXATION STAPLE DRIVER/EXTRACTOR
K832884 · JDR
Warsaw Orthopedic, Inc.
Orthopedic · 55d
Cleared Oct 20, 1983
PERMANTHANE #866 BIPOLAR COAXIAL
K832987 · DTB
Pacesetter Systems
Cardiovascular · 49d
Cleared Oct 20, 1983
PURGES LINES, PL-45 & PL-33
K833048 · DTM
American Bentley
Cardiovascular · 44d
Cleared Oct 20, 1983
BIOTRONIK N, BIPOLAR PEB-60/4-N
K833099 · DTB
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 20, 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
K833106 · DTB
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 20, 1983
OXFORD MARK 2 EXTERNAL FIXATOR
K833114 · JEC
Johnson & Johnson Professionals, Inc.
Orthopedic · 37d
Cleared Oct 20, 1983
TRI-COUNT 7
K833130 · JPK
Hematology Marketing Assoc.
Hematology · 37d
Cleared Oct 19, 1983
VIDEO-DILUTION TECH. MARK I INSTRUMENT
K831057 · DXG
Angio Tec Corp.
Cardiovascular · 201d
Cleared Oct 19, 1983
TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO
K831245 · DXN
Ritter Co.
Cardiovascular · 184d
Cleared Oct 19, 1983
TEMP. REPAIR KIT-DUAL LUMEN CATHETER
K831587 · LJS
Norton Performance Plastics Corp.
General Hospital · 155d
Cleared Oct 19, 1983
KARICKHOFF FLYING CORPUSCLE VIEWER
K831829 · HIX
Surgidev Corp.
Ophthalmic · 134d
Cleared Oct 19, 1983
IONESCU-SHILEY LOW POROSITY COMPOSITE
K831865 · DSY
Shiley, Inc.
Cardiovascular · 131d
Cleared Oct 19, 1983
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
K831880 · DSY
Shiley, Inc.
Cardiovascular · 128d
Cleared Oct 19, 1983
BLOOD OXYGENATOR 50 70/S
K831895 · DTZ
Shiley, Inc.
Cardiovascular · 127d
Cleared Oct 19, 1983
PATIENT MONITOR 788 33A
K831943 · DRT
Hewlett-Packard Co.
Cardiovascular · 125d
Cleared Oct 19, 1983
PATIENT MONITOR #78832A
K831944 · DRT
Hewlett-Packard Co.
Cardiovascular · 125d
Cleared Oct 19, 1983
HARD CONTACT LENS CASE
K831973 · HPX
Moonbeam International, Inc.
Ophthalmic · 121d
Cleared Oct 19, 1983
ACCU-SPHYG
K832060 · DXN
Olympic Medical Corp.
Cardiovascular · 114d
Cleared Oct 19, 1983
CODY SACCULOTOMY TACK
K832068 · ESX
Micromedics, Inc.
Ear, Nose, Throat · 114d
Cleared Oct 19, 1983
SURGICAL STOCKINGS
K832273 · DWL
Wells Johnson Co.
General Hospital · 99d
Cleared Oct 19, 1983
NOVA BALLOON THERMODILUTION INFUSION
K832287 · DYG
Nova Medical Specialties
Cardiovascular · 98d