16 results
·
34ms
·
Sources: EU EUDAMED, US FDA
SENTRY SCALE
FDA 510(k)
FDA Class 1
·General Hospital
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746100086·DB BRACKET MASTER SERIES MAX LEFT CENTRAL 022 T...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746063213·DB BKT MINI MS UL CEN 022 T+22 A+5 R=0
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112750·3M™ Victory Series™ Second Molar Bands, 905-122...
AUTO SUTURE LATCHLESS ABSORBABLE HEMOSTATIC CLIP*
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD PROTECTOR P50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·January 14, 2020
BD PHASEAL PROTECTOR P50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·January 14, 2020
BD PHASEAL PROTECTOR P50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·January 15, 2020
BD PROTECTOR P50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·January 14, 2020
BD PHASEAL PROTECTOR P50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·January 15, 2020
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 29, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 9, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-CLONMEL·Product code NIQ·November 22, 2010
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024