11 results
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25ms
·
Sources: EU EUDAMED, US FDA
CARESIDE ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980056·DeltaForm HighDefinition posterior; shade B1; s...
SPECIALIST
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295251620·SPECIALIST 2 OFFSET MODULAR PLUS TIBIAL TRAY TR...
Genesys Spine AIS-C Cervical Anchored Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
OXYGENATOR HOLDER
FDA 510(k)
FDA Class 2
·Cardiovascular
ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·February 27, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 24, 2011
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·January 28, 1998
ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code GEY·November 28, 2012