10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
FDA 510(k)
FDA Class 2
·Cardiovascular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197534086·Hibbs Retractor set with 2pcs
235mm ...
CT/MR Compatible M.A.C. Interstitial GYN Template
FDA 510(k)
FDA Class 2
·Radiology
S4 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 18, 2019
S4C POLYAXIAL SCREW 3.5X12MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code MNI·May 1, 2009
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MRU·November 14, 2014
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 31, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 29, 2013
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024