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
165793–165816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1980
CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG
K802065 · BSO
Portex, Inc.
Anesthesiology · 13d
Cleared Sep 09, 1980
DISP. TRANSDUCER DOMES TD200 & TD300
K802069 · DRS
Bio-Med Corp.
Cardiovascular · 13d
Cleared Sep 09, 1980
VITAL SIGNS PEEP VALVE
K802070 · BYE
Vital Signs, Inc.
Anesthesiology · 13d
Cleared Sep 06, 1980
PA-1 LOW PRESSURE ALARM
K802112
Puritan Bennett Corp.
Cardiovascular · 3d
Cleared Aug 27, 1980
TALEISNIK TOTAL WRIST PROSTHESIS
K800602 · KWM
Dow Corning Wright
Orthopedic · 163d
Cleared Aug 27, 1980
CYBER 120 HEMODIALYZER
K801377 · FJG
Cyberex Corp.
Gastroenterology & Urology · 77d
Cleared Aug 27, 1980
RTM SYSTEM (REMOTE TEMPERATURE MONITOR)
K801423 · FLL
Remote Technologies, Inc.
General Hospital · 71d
Cleared Aug 27, 1980
SSC8 SORENSON SUBCLAVIAN CATHETER
K801478 · FIQ
Sorensen Research
Gastroenterology & Urology · 64d
Cleared Aug 27, 1980
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
K801479 · KDI
Gambro, Inc.
Gastroenterology & Urology · 64d
Cleared Aug 27, 1980
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ
K801480 · KDI
Gambro, Inc.
Gastroenterology & Urology · 64d
Cleared Aug 27, 1980
THE SIMPLICITY PUMP #2100 INFUSION PUMP
K801546 · FRN
Critikon Company, LLC
General Hospital · 51d
Cleared Aug 27, 1980
NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM.
K801577 · IPF
Inter Med Industries, Inc.
Physical Medicine · 49d
Cleared Aug 27, 1980
GLUCOSE (TRINDER) REAGENT
K801600 · CGA
Gilford Diagnostics
Chemistry · 44d
Cleared Aug 27, 1980
DESERET I.V. FILTER
K801602 · FPB
Hospital Products Co.
General Hospital · 44d
Cleared Aug 27, 1980
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.
K801637 · KPK
C.R. Bard, Inc.
Cardiovascular · 41d
Cleared Aug 27, 1980
PERMITE DENTAL AMALGAM ALLOY
K801639 · EJJ
Southern Dental Industries, Inc.
Dental · 41d
Cleared Aug 27, 1980
FIAX TEST KIT FOR THEOPHYLLINE QUANT.
K801642 · KLS
Intl. Diagnostic Technology
Toxicology · 41d
Cleared Aug 27, 1980
TOTAL PARENTERAL NUTRITION SET BAG
K801652 · KPE
Cutter Laboratories, Inc.
General Hospital · 40d
Cleared Aug 27, 1980
TESTOSTERONE KIT
K801666 · CDZ
Immuchem Corp.
Chemistry · 37d
Cleared Aug 27, 1980
TSH RIASSAY
K801691 · JLW
Ria Diagnostics
Chemistry · 35d
Cleared Aug 27, 1980
SALMONELLA FLAGELLAR A ANTIGEN & B
K801693 · GNC
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Aug 27, 1980
FLOTATION PAD FOR OPERATING TABLE
K801694 · FMP
Action Products, Inc.
General Hospital · 35d
Cleared Aug 27, 1980
SUR-FIT SYSTEM PRE-OPERATION SET
K801702 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 34d
Cleared Aug 27, 1980
MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
K801757 · FES
Medical Measurements, Inc.
Gastroenterology & Urology · 30d