21 results · 39ms · Sources: EU EUDAMED, US FDA

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SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809872330·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY

FDA 510(k)
FDA Class 1 ·Microbiology

NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

PLATE, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code HRS·January 21, 2016

RED DCI-DC3 SENSOR

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·September 15, 2015

RD SET GE - 12

FDA Adverse Event
Malfunction ·Product code DQA·August 13, 2021

MATRIXNEURO STERILE KIT STD 4

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code JEY·December 19, 2013

TI MATRIXNEURO BURR HOLE COVER24MM

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JEY·October 28, 2015

RD SET DCI

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·February 17, 2017

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·April 4, 2013

VITALITY DS VR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

TELIGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·June 23, 2013

MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code JEY·August 28, 2015

Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014

KIT, RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

KIT, RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

KIT, RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

RD SET NEO CS-3

FDA Adverse Event
Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021