18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN
FDA 510(k)
FDA Class 2
·Radiology
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304001992·
Bio-Modular® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868253652·
Plateau-C Ti
FDA UDI
Life Spine, Inc.·00190837066741·Corpectomy Implant Caddy, 14mmx11mm, Angled
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494206·
Stablecut®
FDA UDI
SYNVASIVE TECHNOLOGY, INC.·00846795002726·
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
FDA 510(k)
FDA Class 2
·Microbiology
KOLPLUX SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ARTHROSCOPE
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code HRX·May 15, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 17, 2014
SHILEY CUFFED PEDIATRIC
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO·Product code JOH·June 2, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED, LLC·Product code HWC·July 14, 2025
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED, LLC·Product code HRS·July 14, 2025
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED, LLC·Product code HRS·July 14, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED, LLC·Product code HWC·July 14, 2025
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Enforcement
Class II
·Ongoing·Isopure Corp·July 20, 2022
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018