14 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RETINA CAMERA TRC-NW7SF MARK II
FDA 510(k)
FDA Class 2
·Ophthalmic
BONE GRAFT WASHER
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978958910·WASHER 9090115 TI BONE GRAFT 15MM
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756002752·Wrist Splint
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101150·Distractor, Smooth Paddle, Lordotic, 15mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101150·Distractor, Smooth Paddle, 15mm
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RETIC CHEX LINEARITY
FDA 510(k)
FDA Class 2
·Hematology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 4, 2024
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
ORTHOPILOT CAP SINGLE-USE MARKERS
FDA Adverse Event
Injury
·AESCULAP AG·Product code HAW·February 15, 2022
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 17, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011
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