9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VersaPAP Positive Airway Pressure (PAP) Device
FDA 510(k)
FDA Class 2
·Anesthesiology
CONTROL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295067771·CONTROL CABLE SLEEVE - COBALT CHROME
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Compex Sport Elite
FDA 510(k)
FDA Class 2
·Physical Medicine
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 15, 2014
LUMAX 740 DR-T
FDA Adverse Event
Death
·BIOTRONIK SE & CO. KG·Product code MRM·June 17, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 24, 2011
BD FLUNT FILL NEEDLE WITH FILTER
FDA Adverse Event
Injury
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·February 7, 2020
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013