19 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOL-M EXCHANGEABLE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
ADVIA Centaur® Calibrator G
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414182261·BR CA27-29 (6PK) (US) - CENTAUR - CAL - 6x2x5mL
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
FDA 510(k)
FDA Class 2
·Immunology
TWISTCUT ENDOSORB SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024
PULSE GEN MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 14, 2013
LCS MENIS BEARING STD/15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·May 18, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 20, 2022
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·July 25, 2018
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025