20 results · 23ms · Sources: EU EUDAMED, US FDA

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microTargeting Guideline 4000 5.0 System

FDA 510(k)
FDA Class 2 ·Neurology

SILICONE MAT

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896019362·SILICONE MAT

MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)

FDA 510(k)
FDA Unclassified ·Unknown

BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·January 18, 2022

BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·January 18, 2022

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·December 6, 2021

11CM ANGLE ATTACHMENT, BLACK MAX

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·June 21, 2013

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EYB·July 2, 2024

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·February 28, 2022

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code EZL·July 8, 2022

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·January 15, 2021

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·January 18, 2022

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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