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
169249–169272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1979
NASAL, OXYGEN, CANNULA
K790885 · CAT
Airlife, Inc.
Anesthesiology · 10d
Cleared May 17, 1979
CORRUGATED FLEXIBLE POLYETHYLENE
K790886
Airlife, Inc.
Cardiovascular · 10d
Cleared May 17, 1979
CIRCUIT, BREATHING (W CONNEC, Y PIECE)
K790889
Airlife, Inc.
Cardiovascular · 10d
Cleared May 16, 1979
TEST CELLS
K790249 · KSF
Hyland Therapeutic Div., Travenol...
Hematology · 97d
Cleared May 16, 1979
MICROTEC BACTERIAL FILTER
K790407 · DRS
Medex, Inc.
Cardiovascular · 79d
Cleared May 16, 1979
FINESSE
K790585 · EBF
L.D. Caulk Co.
Dental · 50d
Cleared May 16, 1979
CHEMBOND
K790586 · EMA
L.D. Caulk Co.
Dental · 50d
Cleared May 16, 1979
OMNI-STANICOR-(THETA) MODEL 217
K790690 · DXY
Cordis Corp.
Cardiovascular · 36d
Cleared May 16, 1979
HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID
K790737 · ESD
Hearing Services, Inc.
Ear, Nose, Throat · 30d
Cleared May 16, 1979
COLOSTOMY ENEMA DEVICE
K790749 · EXD
Vabar Corp.
Gastroenterology & Urology · 29d
Cleared May 16, 1979
MODEL H39C-BEHING-THE-EAR HEARING INSTRU
K790779
Marcon Hearing Instruments, Inc.
Gastroenterology & Urology · 23d
Cleared May 16, 1979
ARRHYTHMIA II CARDULE
K790837 · DSI
Spacelabs, Inc.
Cardiovascular · 16d
Cleared May 15, 1979
BLOOD CELL SEPARATOR SYSTEM CS3000
K790315 · FRN
Travenol Laboratories, S.A.
General Hospital · 90d
Cleared May 15, 1979
ROCHE LACTATE ANALYZER 640
K790421 · KHP
Roche Medical Electronics, Inc.
Chemistry · 76d
Cleared May 15, 1979
GAMMA SMAC REAGENTS
K790578 · CIG
Gamma Enterprises, Inc.
Chemistry · 49d
Cleared May 15, 1979
CHROMATOGRAPHY TUBES
K790581 · CDP
Miles Laboratories, Inc.
Chemistry · 49d
Cleared May 15, 1979
ASSAY REAGENTS, LSA 290
K790588 · JEW
Kallestad Laboratories, Inc.
Immunology · 49d
Cleared May 15, 1979
CENTRIFICHEM INORGANIC PHOSPHORUS
K790662 · CED
Union Carbide Corp.
Chemistry · 39d
Cleared May 15, 1979
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
K790665 · CDX
Micromedic Systems
Chemistry · 39d
Cleared May 15, 1979
LD-P REAGENT (LDH P-L REAGENT)
K790771 · CFJ
Gilford Diagnostics
Chemistry · 25d
Cleared May 15, 1979
CULTURETTE BRAND PVA
K790815 · IGM
Marion Laboratories, Inc.
Pathology · 18d
Cleared May 15, 1979
EMIT GENTAMICIN ASSAY
K790829 · DJB
Syva Co.
Toxicology · 15d
Cleared May 15, 1979
EMIT GENTAMICIN CONTROL
K790830 · LAS
Syva Co.
Toxicology · 15d
Cleared May 15, 1979
PERMOBIL EXTERIOR
K790858 · ITI
Saab-Scania of America, Inc.
Physical Medicine · 12d