10 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Shape-HF Cardiopulmonary Testing System
FDA 510(k)
FDA Class 2
·Anesthesiology
Oticon
FDA UDI
Oticon A/S·05707131283887·RIA2, MINIBTE 312 WL 85 SIL
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTEGRA IMMOBILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
CAPTURED HIP SCREW LAG SCREW
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2013
UNKNOWN DEPUY HIP HEAD
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWY·June 29, 2011
BLACKMAX SYSTEM MOTORS
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT·Product code HBB·September 2, 2008
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017