10 results
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24ms
·
Sources: EU EUDAMED, US FDA
VAGABOND SOFT RESTRAINT SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
Modulus
FDA UDI
Nuvasive, Inc.·00195377049889·Modulus ALIF HL Trial, 8x38x30mm 30°
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982178·posteriors; shade A3.5 light; size L; upper jaw
TEPHAFLEX ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
neoBLUE blanket LED Phototherapy System
FDA 510(k)
FDA Class 2
·General Hospital
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·January 18, 2011
O-ARM O2 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OWB·September 27, 2016
COZMO INSULIN PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·September 27, 2006
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