12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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neoBLUE blanket LED Phototherapy System
FDA 510(k)
FDA Class 2
·General Hospital
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 30, 2002
EASY TOUCH
FDA 510(k)
FDA Class 2
·General Hospital
TEPHAFLEX ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 17, 2014
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 7, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION·Product code GZB·June 14, 2013
OXF ANAT BRG RT MD SIZE 7 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·November 24, 2025
OXFORD UNI TWIN-PEG FEMORAL MD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·November 24, 2025
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·April 29, 2024
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·September 12, 2012
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
FDA Recall
Terminated
·Trumpf Medical Systems, Inc.·Product code FSY·May 29, 2012