15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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xvision Spine System
FDA 510(k)
FDA Class 2
·Neurology
Zavation
FDA UDI
Zavation LLC·00842166133051·Ti3Z CIF 14mmx16mmx5mm -9 deg
ZAVATION
FDA UDI
Zavation LLC·00842166105140·CIF 14x16, 9 deg, -05
PRIMROSE MEDICAL, INC.
FDA registration
PRIMROSE MEDICAL, INC.·5 products·🇺🇸 United States
HealthMammo
FDA 510(k)
FDA Class 2
·Radiology
NBX - NON-BRIDGING EXTERNAL FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
BD MICROLANCE¿ 3 NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·January 5, 2023
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 23, 2011
GYNECARE PROLIFT - TOTAL PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON WOMENS HEATH·Product code FTL·October 31, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 11, 2013
DXTEND GLENOSPHERE STD D42MM
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code HSD·July 10, 2023
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
MACH1
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·November 15, 2018
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021