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

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PCA PERIOCARE PERIODONTAL DRESSING

FDA 510(k)
FDA Class 2 ·Dental

MEGA PLUS MIS SPINE SYSTEM

FDA UDI
BK MEDITECH CO.,LTD.·08809916491146·Multi-Axial Cannulated Screw, Ø10.5 x 45mm, Ø5....

Arx

FDA UDI
Life Spine, Inc.·00190837190149·

Arx

FDA UDI
Life Spine, Inc.·00190837130718·

Arx

FDA UDI
Life Spine, Inc.·00190837172602·

Arx

FDA UDI
Life Spine, Inc.·00190837130732·

Arx

FDA UDI
Life Spine, Inc.·00190837130725·

Arx

FDA UDI
Life Spine, Inc.·00190837175542·

Arx

FDA UDI
Life Spine, Inc.·00190837130749·

Arx

FDA UDI
Life Spine, Inc.·00190837188672·

SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)

FDA 510(k)
FDA Class 2 ·Orthopedic

TBW

FDA 510(k)
FDA Class 2 ·Orthopedic

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014

SENSIA SR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·October 31, 2012

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 29, 2015

GALAXY G3 MINI 1.5MM X 4CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 24, 2020

GALAXY G3 MINI 2.5MM X 4.5CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 29, 2020

MICRUSFRAME10 6MM X 26CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·July 14, 2020

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