24 results · 41ms · Sources: EU EUDAMED, US FDA

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HEMOPORE

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

Gyrus ACMI

FDA UDI
Gyrus ACMI, LLC·00821925016828·RICHARDS PISTON 4.5MM LENGTH .4MM DIAMETER PLAT...

3M™ Unitek™

FDA UDI
3M UNITEK CORPORATION·00652221038135·Unitek(TM) Bicuspid Band General Purpose Wide L...

TALOS®-A

FDA UDI
SpineArt SA·07640375237743·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D26 ...

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321418160·

RTX3320PSTN WIRELESS TELEHEALTH GATEWAY

FDA 510(k)
FDA Class 2 ·Cardiovascular

STN PROBE

FDA 510(k)
FDA Class 2 ·Radiology

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

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

OT VERIO TEST STRIPS

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011

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

CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

FDA Enforcement
Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020

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