16 results · 24ms · Sources: EU EUDAMED, 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