14 results · 36ms · Sources: EU EUDAMED, US FDA

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VSI 1000

FDA 510(k)
FDA Class 2 ·General Hospital

TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS

FDA Adverse Event
Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020

TROJAN PLEASURE PACK LUBRICATED CONDOMS

FDA Adverse Event
Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

FDA 510(k)
FDA Class 2 ·Microbiology

LC4200 PCA PLUS AUST

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012

LC4200 PCA AUST

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code MEA·October 20, 2010

PCA PUMP (AUZ)

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012

LC4200 PCA PLUS AUST

FDA Adverse Event
Injury ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012

PCA PUMP (AUZ)

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code MEA·June 2, 2010

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014

STARCLOSE SE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·AV-REDWOOD CITY·Product code MGB·December 2, 2010

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 30, 2012

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024