22 results
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36ms
·
Sources: EU EUDAMED, US FDA
MHS 7000
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
AOS CORTICAL LOCKING SCREW 2.7mm x 18mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009224·
Bone Screws
FDA UDI
ORTHOPEDIATRICS CORP.·00841132133972·4.0 SCREW SYSTEM CASE SCREW CADDY
Vermed
FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·00009336008230·Din Lead Wire .080, Snap to Socket, 18", White
Vermed
FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·00009336008223·Din Lead Wire .080, Snap to Socket, 18", Red
Citrelock ACL 8mm Sizing Tube
FDA UDI
Acuitive Technologies, Inc.·00810027271587·
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·May 3, 2023
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 6, 2019
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710310300180·Talar Osteotmy Guide, 30mm x 18mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710820300180·Zadik Calcaneal Guide, 30mm x 18°
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710300300180·Tibial Osteotmy Guide, 30mm x 18mm
TITAN TIBIAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
BRANEMARK NOVUM
FDA 510(k)
FDA Class 2
·Dental
ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code BSP·November 21, 2019
APPLICAT OUT SHAFT
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code LXH·April 2, 2013
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 4
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·March 25, 2011
ACCU-CHEK RAPID D INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·April 14, 2008
ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 5, 2023
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024