9 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CrossTie Intraosseous Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
ORTHOSIS,PEDICLE SPINAL FIXATION
FDA Adverse Event
Injury
·SYNTHES USA·Product code MNI·December 8, 2015
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·March 25, 2015
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014