15 results · 23ms · Sources: EU EUDAMED, US FDA

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COLORADO MICRODISSECTION NEEDLE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033232·Baltic Denture System BDLoad BDLoad Mm7 PLSEbi...

Ortho Organizers

FDA UDI
Ortho Organizers, Inc.·00190707023690·CNA PALATAL ARCH 32mm

RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)

FDA 510(k)
FDA Class 1 ·General Hospital

CYBERCASES BY BAUSCH & LOMB

FDA 510(k)
FDA Class 2 ·Ophthalmic

ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code NIQ·April 3, 2013

PRECISION SPECTRA®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 25, 2014

SCREW,2.4X10MM CANCELOUS LOCKNG

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·March 30, 2011

POLYMOBIL PLUS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·July 27, 2023

EVOLUT FX VALVE

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

ARCHITECT IPTH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code CEW·March 19, 2025

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024