344 results
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48ms
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Sources: EU EUDAMED, US FDA
Visensia
FDA UDI
OBS MEDICAL LIMITED·05060457930010·Visensia® software is a computerized analysis s...
UNKNOWN OTOLOGY
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code EQJ·August 8, 2014
OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Laparoscopy OB GYN Pack, Catalog number 900-1192. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
COMBUR 10 UX 100
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JIL·December 13, 2019
OCTRODE 8 PERCUTANEOUS LEAD
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·June 30, 2010
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Injury
·MEDELA, INC.·Product code HGX·January 15, 2013
PUMP IN STYLE (UNKNOWN)
FDA Adverse Event
Injury
·MEDELA LLC·Product code HGX·January 17, 2017
BREASTPUMP PNSA STARTER
FDA Adverse Event
Injury
·MEDELA LLC·Product code HGX·June 6, 2017
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 13, 2025
MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.
FDA Recall
Open, Classified
·Product code MLS·May 4, 2026
BP ADVANCED PERSONAL DOUBLE
FDA Adverse Event
Injury
·MEDELA, INC.·Product code HGX·October 30, 2014
EQUINOXE PRIMARY SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 3, 2025
FREESTYLE HANDS-FREE BREASTPUMP
FDA Adverse Event
Injury
·MEDELA AG·Product code HGX·November 9, 2016
PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
FDA Adverse Event
Injury
·MEDELA LLC·Product code HGX·April 26, 2017
PUMP IN STYLE ADVANCED BREASTPUMP STARTER
FDA Adverse Event
Injury
·MEDELA INC.·Product code HGX·January 20, 2015
PUMP IN STYLE ADVANCED BREASTPUMP STARTER
FDA Adverse Event
Injury
·MEDELA INC.·Product code HGX·July 20, 2015