14 results · 23ms · Sources: EU EUDAMED, US FDA

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VISUALASE THERMAL THERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Harvard Temp C&B A3

FDA UDI
Harvard Dental International GmbH·EHAR70816561·Temporary crown and bridge material 10:1

AVALIGN

FDA Adverse Event
Malfunction ·AVALIGN GERMAN SPECIALTY INSTRUMENTS·Product code HAE·June 17, 2019

HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4

FDA 510(k)
FDA Class 2 ·Radiology

HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRECISION MONTAGE MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 22, 2023

CADD MEDICATION CASSETTE

FDA Adverse Event
Malfunction ·NULL·Product code FPA·February 4, 2022

TOTAL ASR FEM IMP SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·April 29, 2013

PALMAZ GENESIS OPTA PRO

FDA Adverse Event
Malfunction ·CORDIS DE MEXICO·Product code FGE·May 9, 2011

PUMP MMT-722LNAB PRDGM INS BL EN ML

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·July 23, 2008

Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S

FDA Enforcement
Class II ·Terminated·Stryker GmbH·July 18, 2018

Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S

FDA Enforcement
Class II ·Terminated·Stryker GmbH·July 18, 2018

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018