14 results · 28ms · Sources: EU EUDAMED, US FDA

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Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

FDA 510(k)
FDA Class 2 ·Cardiovascular

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676221616000·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676221616070·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676221616150·

Symmetry Roux

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482059265·Symmetry® Retractor, Roux, 1 1/4 in Wide, 1 3/4...

DynaClip Quattro

FDA UDI
Medshape, Inc.·M9703000112216160·QUATTRO DYNACLIP STAPLE, 22X16X16

SyMRI

FDA 510(k)
FDA Class 2 ·Radiology

DELIGHT DENTAL ER: YAG LASER SYSTEM

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

HNM Medical

FDA UDI
HNM STAINLESS, LLC.·00842962113875·ROUX RETRACTOR, 6 1/4", LARGE, DOUBLE ENDED, LONG

ENDO GIA UNIVERSAL 12MM SINGLE USE INST

FDA Adverse Event
Injury ·UNITED STATES SURGICAL·Product code GDW·August 19, 2011

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 3, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 11, 2013

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