22 results · 30ms · Sources: EU EUDAMED, US FDA

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ADI Cervical Interbody Fusion Device

FDA 510(k)
FDA Class 2 ·Orthopedic

Custom Healthcare Systems, Inc.

FDA UDI
Manus Medical, LLC·00811870033414·

Compression Staple System

FDA UDI
TORNIER, INC.·00846832058808·Staple

FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS

FDA 510(k)
FDA Class 2 ·Dental

CONSTRUX MINI PEEK SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025

STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021

STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022

ZEPHYR XL DR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 4, 2011

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·June 26, 2013

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

FDA Enforcement
Class I ·Ongoing·Medline Industries, LP·May 20, 2026

M-VIZION PROXIMAL BODY HANDLE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026

STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021

M-VIZION INSERTER ROD

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016