9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HBO CABLE ASSEMBLY, RADIOMETER TC-02
FDA 510(k)
FDA Class 2
·Anesthesiology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221113320·3M™ Victory Series™ Second Molar Bands, 905-225...
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
FDA 510(k)
FDA Class 1
·General Hospital
ROMCHECK SPECIMEN COLLECTION KIT
FDA 510(k)
FDA Class 1
·Microbiology
VERITY ADX XL
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·January 9, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·May 28, 2014
AVEA
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·June 24, 2015
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 15, 2011
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