9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ERBE ERBEJET 2 SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
FDA 510(k)
FDA Class 2
·Cardiovascular
MICRO-MAX, MODEL 319
FDA 510(k)
FDA Class 2
·Radiology
ECHELON*FLEX45
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 23, 2013
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 8, 2011
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008
IMMULITE 2000 Intact PTH kit
FDA Recall
Terminated
·Diagnostic Products Corp·Product code CEW·February 23, 2004
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015