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
140977–141000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1987
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
K862226 · DXY
Pacesetter Systems
Cardiovascular · 237d
Cleared Feb 03, 1987
MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER
K862383 · DSB
Rjl Systems, Inc.
Cardiovascular · 224d
Cleared Feb 03, 1987
OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES
K862402 · NVE
Medivators, Inc.
General Hospital · 223d
Cleared Feb 03, 1987
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K862462 · BZQ
Nihon Kohden America, Inc.
Anesthesiology · 218d
Cleared Feb 03, 1987
CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
K863100 · DPS
Honeywell, Inc.
Cardiovascular · 174d
Cleared Feb 03, 1987
TECA/MEDELEC AUDIOSTAR
K863156 · GWJ
Teca, Inc.
Neurology · 169d
Cleared Feb 03, 1987
COOK-VPI CONTINENCE CUFF
K863227 · FHA
Cook Urological, Inc.
Gastroenterology & Urology · 166d
Cleared Feb 03, 1987
LEECO VIS-CUBE STREP A (EIA)
K864170 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 102d
Cleared Feb 03, 1987
PENLON CIRCLE SYSTEM
K864588 · CAI
Bear Medical Systems, Inc.
Anesthesiology · 74d
Cleared Feb 03, 1987
VAPLOK
K864605 · CAD
Bear Medical Systems, Inc.
Anesthesiology · 71d
Cleared Feb 03, 1987
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
K864619 · KRL
Shiley, Inc.
Cardiovascular · 71d
Cleared Feb 03, 1987
GC-LECT(TM)
K864803 · JTY
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Feb 03, 1987
TUPPER TROLLEY
K870102 · HST
Orthopedic Systems, Inc.
Neurology · 25d
Cleared Feb 03, 1987
FEMUR WRENCH
K870126 · GEG
Orthopedic Systems, Inc.
General & Plastic Surgery · 22d
Cleared Feb 03, 1987
URESIL T-SYSTEM BONE SCREWS
K870141 · HWC
Uresil Corp.
Orthopedic · 21d
Cleared Feb 02, 1987
THE GOLDEN QUAD TEST (HSV)
K861120 · GQO
Microbiological Research Corp.
Microbiology · 314d
Cleared Feb 02, 1987
THE GOLDEN QUAD TEST (EBV)
K861121 · GNP
Microbiological Research Corp.
Microbiology · 314d
Cleared Feb 02, 1987
THE GOLDEN QUAD TEST (TOXO)
K861122 · LJK
Microbiological Research Corp.
Microbiology · 314d
Cleared Feb 02, 1987
THE GOLDEN QUAD TEST (CMV)
K861123 · GQI
Microbiological Research Corp.
Microbiology · 314d
Cleared Feb 02, 1987
OSTEOPAK BMD (BONE MINERAL DENSITOMETER)
K861515 · KGI
Siemens Gammasonics, Inc.
Radiology · 285d
Cleared Feb 02, 1987
EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND
K862859 · DXK
Biosound, Inc.
Cardiovascular · 188d
Cleared Feb 02, 1987
MICRODILUTION MIC PANELS
K863776 · JWY
American Micro Scan
Microbiology · 130d
Cleared Feb 02, 1987
CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY
K864315 · LFX
Cytotech, Inc.
Microbiology · 91d
Cleared Feb 02, 1987
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA
K864347 · GNP
Granbio, Inc.
Microbiology · 90d