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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81289–81312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 2000
BAUMER FEMORAL HEAD
K001571 · JDI
Baumer, S.A
Orthopedic · 74d
Cleared Aug 04, 2000
STRYKER TRAUMA PELVIC SET
K001614 · KTW
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Aug 04, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K001645 · GKP
Dade Behring, Inc.
Hematology · 66d
Cleared Aug 04, 2000
PASCO MIC AND MIC/ID PANELS
K001721 · LTT
Pasco Laboratories, Inc.
Microbiology · 59d
Cleared Aug 04, 2000
STIMULAN -CALCIUM SULFATE BONE VOID FILTER
K001724 · MQV
Biocomposites, Ltd.
Orthopedic · 59d
Cleared Aug 04, 2000
ACCELERATOR RECIPROCATING CANNULA
K001803 · QPB
Byron Medical
General & Plastic Surgery · 51d
Cleared Aug 04, 2000
DORO HEADREST SYSTEM
K001808 · HBL
Pro-Med Instruments GmbH
Neurology · 50d
Cleared Aug 04, 2000
CLEARFIL ST OPAQUER
K001913 · EBF
Kuraray Company, Ltd.
Dental · 42d
Cleared Aug 04, 2000
CERALAS D10 810NM LASER, MODEL CERALAS D10-60
K001975 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 36d
Cleared Aug 04, 2000
EEI SLUSH PAN DRAPE
K001994 · KKX
Eagle Endoscopic, Inc.
General Hospital · 35d
Cleared Aug 04, 2000
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL...
K002107 · MVM
Scimedx Corp.
Immunology · 23d
Cleared Aug 04, 2000
MODEL 9000 PEDIATRIC WHEELCHAIR
K002170 · IOR
Invacare Corp.
Physical Medicine · 16d
Cleared Aug 04, 2000
ALLEGIANCE GENESIS CONTAINER SYSTEM
K983299 · FRG
Allegiance Healthcare Corp.
General Hospital · 683d
Cleared Aug 04, 2000
MICROTARGETING ELECTRODE
K991522 · GZL
FHC, Inc.
Neurology · 459d
Cleared Aug 04, 2000
ARTHREX CHONDRAL DART, MODEL AR-4005B-18
K991971 · HTY
Arthrex, Inc.
Orthopedic · 420d
Cleared Aug 04, 2000
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR...
K992133 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 408d
Cleared Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · JXG
Radionics, Inc.
Neurology · 399d
Cleared Aug 04, 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166 · HWC
Stryker Endoscopy
Orthopedic · 317d
Cleared Aug 04, 2000
R.TEST EVOLUTION
K993788 · MLO
Novacor Div.
Cardiovascular · 269d
Cleared Aug 04, 2000
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
K994399 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Aug 04, 2000
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
K994400 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Aug 03, 2000
BREAS PV 100 CPAP SYSTEM
K001553 · BZD
Vital Signs, Inc.
Anesthesiology · 77d
Cleared Aug 03, 2000
TAMPONS
K001641 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 65d
Cleared Aug 03, 2000
WATER PURIFIER
K001878 · EIA
Waterclave, LLC
Dental · 44d