15 results · 24ms · Sources: EU EUDAMED, 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