16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Voluson P6 and Voluson P8
FDA 510(k)
FDA Class 2
·Radiology
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G586G1805350·virtus (ralks) splinter forceps, 6" (15.2 cm), ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197453233·CCR Titanium Longitudinal Blade
24x35m...
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
FDA 510(k)
FDA Class 2
·General Hospital
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LINER: MPACT FLAT PE HC LINER Ø32/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·November 17, 2021
LINER: MPACT FLAT PE HC LINER Ø32/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·June 10, 2020
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
GM HELIX ACQUA IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019
ADULT ROTATING CRANIOTOME
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 20, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 27, 2011
GM HELIX IMPLANT 6.0X8
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019
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