25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECTROCARDIOGRAPH TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Bioseal Inc.
FDA UDI
BIOSEAL·00630094192390·00630094192390
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111062·INSTRUMENT CASE MEDIUM ALUMINUM
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 11, 2009
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 11, 2009
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 11, 2009
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 11, 2009
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 11, 2009
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 11, 2009
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 22, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·December 13, 2010
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 2014
UNK DVR PLATE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRS·October 20, 2017
SUPERDIMENSION
FDA Adverse Event
Malfunction
·COVIDIEN LP - SUPERDIMENSION INC·Product code JAK·September 3, 2025
COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·July 30, 2025
TALENT TAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 7, 2016
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 7, 2016
COMPREHENSIVE REVERSE SHOULDER SYSTEM VIVACIT-E- HIGHLY CROSSLINKED POLYETHYLENE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·July 30, 2025