35 results · 28ms · Sources: EU EUDAMED, US FDA

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LEXIPLIANT DILATOR SHEATH SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

KneeAlign 2

FDA UDI
Orthalign, Inc.·00858704006008·KneeAlign 2 Unit

KneeAlign 2

FDA UDI
Orthalign, Inc.·00810832031376·KneeAlign 2 Unit

MODIFICATION TO COATEST FACTOR VIII

FDA 510(k)
FDA Class 2 ·Hematology

SLEEPMINDER BREATHING FREQUENCY INDICATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

TPRLC XR T1 PPS 17X154MM MM T1

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code OQG·February 25, 2020

TPRLC XR T1 PPS 14X148MM MM T1

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code OQG·February 25, 2020

TPRLC 133 FP TYPE1 PPS SO 5.0

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code OQG·February 25, 2020

PENTA

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

UNKNOWN ZIMMER KNEE IMPLANT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·June 16, 2011

BRAVO

FDA Adverse Event
Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·August 20, 2008

ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022

ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015

FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018

ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·December 19, 2014

ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·November 1, 2016

ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 29, 2016

ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·June 15, 2016