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
165721–165744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1980
PDS MODEL 3000 ADULT RESPIRATION MODULE
K802046 · BZQ
General Electric Co.
Anesthesiology · 22d
Cleared Sep 16, 1980
NIMETIC-DISPERS
K802049 · EBF
Espe Dental Products
Dental · 22d
Cleared Sep 16, 1980
TACKMER INCISE DRAPE
K802050 · KKX
American Convertors Div., American...
General Hospital · 22d
Cleared Sep 16, 1980
OXYGEN SUPPLY TUBING
K802071 · BYX
Auburn Components
Anesthesiology · 20d
Cleared Sep 16, 1980
MUELLER STRETCH M TAPE
K802073 · KGX
Mueller Chemical Co.
General & Plastic Surgery · 20d
Cleared Sep 16, 1980
HOLLOW FIBER DIALYZER HOLDER
K802075 · FKI
Renal Devices, Inc.
Gastroenterology & Urology · 20d
Cleared Sep 16, 1980
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · DWS
Howmedica Corp.
Cardiovascular · 19d
Cleared Sep 16, 1980
CATHETER INSERTION TRAY
K802083 · KOD
Walpak Co.
Gastroenterology & Urology · 18d
Cleared Sep 16, 1980
INTRACRANIAL PRESSURING MONITORING SYST.
K802100 · GWM
Pudenz-Schulte Medical Research Corp.
Neurology · 13d
Cleared Sep 16, 1980
I.V. SENTRY ALARM DEVICE
K802101 · FLN
Pike Medical Co.
General Hospital · 13d
Cleared Sep 16, 1980
C-SPLINT
K802104 · IQI
Cutter Laboratories, Inc.
Physical Medicine · 13d
Cleared Sep 16, 1980
C-BLADE
K802105 · HWE
Cutter Laboratories, Inc.
Orthopedic · 13d
Cleared Sep 16, 1980
SHILEY UTILITY RESERVOIR
K802119 · DTN
Shiley, Inc.
Cardiovascular · 12d
Cleared Sep 16, 1980
MONOSPHERICAL SHOULDER PROSTHESIS
K802123 · HSD
Howmedica Corp.
Orthopedic · 12d
Cleared Sep 16, 1980
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K802125 · EBF
Dentsply Intl.
Dental · 12d
Cleared Sep 16, 1980
BACITRACIN DIFFERENTIATION DISC
K802127 · JTO
Biomedia, Inc.
Microbiology · 13d
Cleared Sep 16, 1980
SHILEY TEMPERATURE MONITOR
K802147 · FLL
Shiley, Inc.
General Hospital · 11d
Cleared Sep 16, 1980
COMPOSITE RESTORATIVE
K802262
L.D. Caulk Co.
Dental
Cleared Sep 12, 1980
QUINTREX 0515 PROGRAMMABLE PULSE GEN.
K802223
Medcor, Inc.
Cardiovascular
Cleared Sep 12, 1980
QUINTREX 0516 PROG. PULSE GENERATOR SYS
K802224
Medcor, Inc.
Cardiovascular
Cleared Sep 10, 1980
STERILE DISPOSABLE CYTOLOGY BRUSH
K802187
Olympus Corp.
Gastroenterology & Urology
Cleared Sep 09, 1980
AMS MALLEABLE OR JONAS SILICONE-SILVER
K792724 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 253d
Cleared Sep 09, 1980
MEDTRONIC MODEL 2409
K800226 · DXY
Medtronic Vascular
Cardiovascular · 217d
Cleared Sep 09, 1980
VOCON MODEL VC526
K801314 · FSO
Teknar, Inc.
General & Plastic Surgery · 98d