17 results · 25ms · Sources: EU EUDAMED, US FDA

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Philips IntelliVue GuardianSoftware

FDA 510(k)
FDA Class 2 ·Cardiovascular

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197385435·HEGAR-BAUMGARTNER TC Needle Holder 125mm,...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197385442·HEGAR-BAUMGARTNER TC Needle Holder 140mm,...

GM HELIX IMPLANT 6.0X10

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019

DIPLOMAT

FDA 510(k)
FDA Class 1 ·Dental

RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

GM HELIX IMPLANT 6.0X8 MM

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019

GM HELIX IMPLANT 6.0X10

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019

CUP: MPACT ACETABULAR SHELL Ø50 MULTI-HOLE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·November 14, 2018

GM HELIX ACQUA IMPLANT 6.0X10

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019

JAGWIRE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·October 17, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·July 27, 2011

ASR UNI FEMORAL IMPL SIZE 49

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·June 20, 2013

GM HELIX IMPLANT 6.0X8

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019

ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024