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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
Smith & Nephew, Inc.·00885554012750·MTO ARTHROSCOPE 4.0 X 45 DEG

VEO® Lateral Interbody Fusion System

FDA UDI
Choice Spine, LP·00840996133609·LATERAL,BONE GRAFT INSERTER,PLUNGER

PEDICLE SCREW 03.58.225 MUST MC SCREW Ø5X45 CANNULATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2023

PASS LP SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300

FDA 510(k)
FDA Class 2 ·Cardiovascular

M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·April 9, 2026

M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2025

M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·July 11, 2025

MYSPINE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·September 27, 2024

EXTENSION, 30 CM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 10, 2011

POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

FDA Adverse Event
Malfunction ·CORDIS CORPORATION·Product code LIT·October 29, 2014

RIATA ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

GALAXY G3 MINI 2MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

CASH 14 PLAT COIL 4MMX6CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

GALAXY G3 MINI 2MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

PEDICLE SCREW MUST MC SCREW Ø6X45

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·December 21, 2022

GALAXY G3 MINI 3MM X 6CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

"E-LINE" URETERORENOSCOPE

FDA Adverse Event
Malfunction ·RICHARD WOLF GMBH·Product code FGB·April 10, 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