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
157417–157440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357 · DQO
C.R. Bard, Inc.
Cardiovascular · 126d
Cleared Mar 11, 1983
FERRITIN IMMUNORADIOMETRIC ASSAY KIT
K823829 · DFB
Bd Becton Dickinson Vacutainer...
Chemistry · 81d
Cleared Mar 11, 1983
CAPD COLOR-GUARD SYSTEM PREPKIT
K830002 · FKY
Abbott Laboratories
Gastroenterology & Urology · 67d
Cleared Mar 11, 1983
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-
K830167 · KRI
American Bentley
Cardiovascular · 52d
Cleared Mar 11, 1983
SKIN SCRUB PREP. TRAY
K830281 · FRG
Zoa, Inc.
General Hospital · 44d
Cleared Mar 11, 1983
ESOPHAGEAL STETHOSCOPE
K830329 · BZW
Science Development Corp.
Anesthesiology · 38d
Cleared Mar 11, 1983
PEEPER
K830395 · BYE
Dupaco, Inc.
Anesthesiology · 32d
Cleared Mar 11, 1983
CONTOX DURG CONTROL
K830492 · DIF
Kaulson Laboratories, Inc.
Toxicology · 23d
Cleared Mar 11, 1983
CONTOX DRUG SCREEN CONTROL
K830494 · DIF
Kaulson Laboratories, Inc.
Toxicology · 23d
Cleared Mar 11, 1983
MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM
K837110
Bio Quantum Technologies, Inc.
Radiology · 63d
Cleared Mar 10, 1983
NO-BOIL SOLID PHASE SIMUL TRAC B12
K822721 · CDD
Bd Becton Dickinson Vacutainer...
Chemistry · 184d
Cleared Mar 10, 1983
PATCH
K823345 · DXZ
Shiley, Inc.
Cardiovascular · 122d
Cleared Mar 10, 1983
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
K823863 · DXY
Intermedics, Inc.
Cardiovascular · 78d
Cleared Mar 10, 1983
MICRO FITNESS COMPUTER
K830003 · DXG
Microfit, Inc.
Cardiovascular · 66d
Cleared Mar 10, 1983
RICH-MAR HV 20
K830055 · IPF
Rich-Mar Corp.
Physical Medicine · 57d
Cleared Mar 10, 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K830155 · DHB
Pharmacia, Inc.
Chemistry · 51d
Cleared Mar 10, 1983
DIGIFLEX AUTOMATIC PIPETTE
K830157 · JQW
Micromedic Systems
Chemistry · 51d
Cleared Mar 10, 1983
AUTOMATED ELISA READER LBI 300
K830227 · JTQ
Bionetic Laboratory Products
Chemistry · 45d
Cleared Mar 10, 1983
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K830307 · KWL
Howmedica Corp.
Orthopedic · 38d
Cleared Mar 10, 1983
AIRCARE 300
K830324 · CAW
Med.Com
Anesthesiology · 37d
Cleared Mar 10, 1983
SALT BRIDGE SOLUTION & URINE DILUENT
K830341 · JIX
Shaban Mfg. Co.
Chemistry · 36d
Cleared Mar 10, 1983
SCOOTER, VEHICLE MOTORIZED
K830345 · INI
Amigo Sales, Inc.
Physical Medicine · 41d
Cleared Mar 10, 1983
KINETI COUNT 48 IMMUNOASSAY SYSTEM
K830365 · JJJ
Medical & Scientific Designs, Inc.
Chemistry · 34d
Cleared Mar 10, 1983
TDX METHOTREXATE
K830398 · LAO
Abbott Laboratories
Chemistry · 31d