22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OTOMAG BONE CONDUCTION HEARING SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 31, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 19, 2022
ONE TOUCH BASIC ENHANCED
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·November 20, 2002
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·September 12, 2019
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 4, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·September 29, 2008
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 2, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·February 12, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·March 8, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·February 18, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 3, 2020
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 2, 2020
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·July 26, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·November 20, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·November 8, 2019
STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 0 12/14
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 17, 2019