16 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ERCHONIA ZERONA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HYBRID GRAFT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 19, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 3, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 4, 2019
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 13, 2014
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·May 14, 2013
TRANSVENE SVC/CS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·June 13, 2011
¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTL·September 23, 2015
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 24, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 14, 2020
ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code FTL·August 8, 2014
¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTL·November 30, 2015
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024