8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CIRCUITGUARD CIRCUITGUARD HME
FDA Adverse Event
Other
·ARC MEDICAL INC., ANESTHESIA & RESPIRATORY CARE·Product code BYD·July 20, 2005
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
FDA 510(k)
FDA Class 2
·Cardiovascular
Sterile High-pressure Angiographic Syringes for Single-use
FDA 510(k)
FDA Class 2
·Cardiovascular
GOLD RELOAD FOR ECHELON
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 28, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 1, 2011
PARADIGM QUICKSERTER
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code KZH·August 5, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024