13 results · 20ms · Sources: EU EUDAMED, US FDA

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LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Oticon

FDA UDI
Oticon A/S·05707131259257·NERA, KIT 312 WL DIR R V BE

PEDICLE SCREW MONOAXIAL SCREW 5X40MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 10, 2019

GE LOGIQ P5 MODEL H44662LD

FDA 510(k)
FDA Class 2 ·Radiology

PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

OT VERIO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
MEDTRONIC MINIMED·Product code OYC·October 1, 2014

MUST PEDICLE SCREW 8X40MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2017

INTELLIVUE MX500 PATIENT MONITOR

FDA Adverse Event
Death ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 4, 2023

FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

FDA Adverse Event
Malfunction ·MAQUET CV·Product code DSY·February 8, 2017

PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWP·July 4, 2018

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015