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
171841–171864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1978
MDL-201
K772051 · DXY
Pacesetter Systems
Cardiovascular · 91d
Cleared Jan 30, 1978
PACEMAKER, PERM. & TEMP., ELECTRODE
K772197 · DTB
Daig Corp.
Cardiovascular · 66d
Cleared Jan 30, 1978
LENS, HARD RESIN
K772221 · HQG
Borani Intl.
Ophthalmic · 56d
Cleared Jan 30, 1978
PULSE GENERATOR, UNIPOLAR, PROGRAMABLE
K772238 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
PULSE GENERATOR, BIPOLAR, PROGRAMMABLE
K772239 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
PULSE GENERATOR, UNIPOLAR, DEMAND
K772240 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
PULSE GENERATOR, BIPOLAR, DEMAND
K772241 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
CATHETER, CHOLANGIOGRAM, OPERATIVE
K772288 · GBZ
Gesco Intl., Inc.
General & Plastic Surgery · 49d
Cleared Jan 30, 1978
X-RAY CO-ORDINATOR
K772313 · IWY
Rinn Corp.
Radiology · 49d
Cleared Jan 30, 1978
ETHYLENE OXIDE STERILI. INDICATOR
K772358 · JOJ
Bio-Medical Sciences, Inc.
General Hospital · 34d
Cleared Jan 30, 1978
LASER IMMUNONEPHELOMETRIC ANALYZER
K772361 · JQX
G.D. Searle and Co.
Chemistry · 34d
Cleared Jan 30, 1978
SPECTACLE FRAME, OP-TITE
K772368 · HQZ
Dentsply Intl.
Ophthalmic · 34d
Cleared Jan 30, 1978
17-HYDROXY TEST
K772426 · CDB
Hycel, Inc.
Chemistry · 34d
Cleared Jan 30, 1978
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE
K780013 · CIT
Macomb Chemical Co.
Chemistry · 27d
Cleared Jan 30, 1978
AUTO. SLIDE STAINER
K780017 · KPA
Honeywell, Inc.
Hematology · 27d
Cleared Jan 30, 1978
CARDIAC PACER, MODEL 208
K780066 · DXY
Cordis Corp.
Cardiovascular · 18d
Cleared Jan 30, 1978
OXYGEN THERAPY KIT
K780084 · CAN
Thermadyne Holings Corp.
Anesthesiology · 14d
Cleared Jan 30, 1978
CANE/REACHER
K780085 · IPS
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Jan 30, 1978
INFUSION APPARATUS, POWERED
K780086 · FRN
Ohio Medical Products
General Hospital · 17d
Cleared Jan 30, 1978
MICROPULSE 22U
K780091 · DXY
Edwards Pacemaker Systems
Cardiovascular · 14d
Cleared Jan 30, 1978
ANALYZER-PLUG-IN, CO2 MODEL M 3104
K780107 · CCK
Electronics For Medicine, Inc.
Anesthesiology · 11d
Cleared Jan 30, 1978
SPECTROPHOTOMETER, MODEL 5000
K780112 · JXR
The Perkin-Elmer Corp.
Toxicology · 11d
Cleared Jan 30, 1978
SCANNERS, TOMOGRAPHIC, COMPUTED
K780115 · JAK
Ohio Nuclear, Inc.
Radiology · 11d
Cleared Jan 26, 1978
CILCO ANTERIOR CHAMBER LENS
K771933 · HQL
California Intraocular Lens
Ophthalmic · 104d