30 results
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29ms
·
Sources: EU EUDAMED, US FDA
VENUS FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
CoRoent
FDA UDI
Nuvasive, Inc.·00887517564566·CoRoent Ant TLIF PEEK, 12x10x34mm 0°
N/A
FDA UDI
Tyber Medical, LLC·M695M1203400·
i.Terminal mobile
FDA UDI
Carl Zeiss Vision GmbH·04250668606649·N/A
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
FDA Enforcement
Class II
·Terminated·Ad-Tech Medical Instrument Corporation·September 29, 2021
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529587291·Apex Femoral Nail GT Right Ø 12.0 x 340mm
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481475494·
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529581404·Apex Femoral Nail PF Left Ø 12.0 x 340mm
BullDog®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734023518·Disposable Bronchoscope Valves Set
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529585495·Apex Femoral Nail PF Right Ø 12.0 x 340mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529586393·Apex Femoral Nail GT Left Ø 12.0 x 340mm
NATRELLE Silicone-Filled Breast Implants
FDA UDI
Allergan, Inc.·10888628002548·NATRELLE Style 120-340 High profile BIOCELL |te...
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529588274·Apex Femoral Nail Retrograde Ø 12.0 x 340mm
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
REPROCESSED SURGICAL ELECTRIC INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·November 30, 2018
STYLE 120 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·August 26, 2020
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
Truliant
FDA UDI
Exactech, Inc.·10885862314918·Truliant PS Porous Femoral
PROPLEGE CORONARY SINUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·May 20, 2013