14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Silicone Round Double Drain
FDA UDI
C. R. Bard, Inc.·00801741049538·Silicone Round Double Drain, Medium 1/8" (10Fr....
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0107100·Tamp, Rotating
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023796·Angled Tamp
MD 10, SEM, SM 12, CBM
FDA 510(k)
FDA Class 1
·Dental
SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 30, 2025
12.0MM/8.0MM PROTECTION SLEEVE188MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code LXH·April 22, 2013
PROXIMATE** RELOADABLE LINEAR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 27, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·July 2, 2008
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
FDA Enforcement
Class II
·Terminated·ArthroCare Medical Corporation·December 17, 2014
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020