20 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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