18 results · 19ms · Sources: EU EUDAMED, US FDA

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Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

FDA 510(k)
FDA Class 2 ·General Hospital

ORTHOCORD HEALIX BR

FDA UDI
Medos International Sàrl·10886705007783·HEALIX BR Anchor w/ORTHOCORD w/Needles TCP/PLGA...

CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

GMK NARROW

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017

GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·April 19, 2024

Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·February 6, 2024

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 15, 2022

GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 27, 2016

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2016

Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

GMK PS TIBIAL INSERT SIZE 3 / 17 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·June 11, 2015

Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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