220 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAXCUT CARBIDE BUR (10/pk) RASU # 8
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811118591·MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ...
Flexitron
FDA UDI
Nucletron B.V.·08717213027008·Flexitron Transfer Tube for 4F Flexibles (9)
Plum XLD, list numbers 11859-04-01, 11859-04-03, 11859-04-05, 11859-04-07, 11859-04-09, 11859-04-11, 11859-04-13, 11859-04-51, 12570-04-01 (veterinary); AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
FDA Recall
Terminated
·Hospira Inc·Product code FRN·August 11, 2009
KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
FDA 510(k)
FDA Class 2
·Cardiovascular
REL-K ARTIFICAL LIMB PROSTHESIS
FDA 510(k)
FDA Class 1
·Physical Medicine
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·November 22, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·December 6, 2019
GUARDIAN ROLLING WALKER
FDA Adverse Event
Malfunction
·A&E·Product code ITJ·November 4, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 14, 2013
ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code FEB·August 13, 2008
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·June 27, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·October 17, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMP,TSV,MCOL MG,3.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 23, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 1, 2023