21 results · 30ms · 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.

ENCORE 26 ADVANTAGE KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

Starbond Easy

FDA UDI
S & S Scheftner GmbH·04260207854288·Powder 45, 5kg

ForPro

FDA UDI
Tng Worldwide, Inc.·00672047000970·Blue Nitrile Exam Gloves Size Small 100ct

Gyrus ACMI

FDA UDI
Gyrus ACMI, LLC·00821925016484·TRAPEZE RIBBON LOOP 5 MM LENGTH PLATINUM

SSW CARBIDE

FDA UDI
Ss White Burs, Inc.·D6901407452·FG SL CARBIDE 1702 - 5 PACK

Cancellous Screw, Cannulated

FDA UDI
I.T.S. GmbH·09120034307898·Cancellous Screw, Cannulated, D=4.0mm, L=45m

OsteoMed

FDA UDI
OSTEOMED LLC·00845694046336·PrimaLIF LLIF PEEK Implant, 7mm X 26mm X 45mm, ...

PEEK Temporary Abutment

FDA UDI
BICON, LLC·00813110027863·4.0 x 4.5mm PEEK Temporary Abutment - 2.0mm Post

LIFEBED NETWORK PATIENT VIGILANCE SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFIED CONCENTRIC RETRIEVER, MODEL 90038

FDA 510(k)
FDA Class 2 ·Cardiovascular

STEM: AMISTEM H HA COATED STD STEM SIZE 1

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 29, 2020

AMISTEM H, HA COATED STEM SIZE 1 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 6, 2017

BD SLIP TIP SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·January 28, 2023

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 3, 2014

M2A 38MM MOD HD -3MM NK

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 31, 2013

ZOOM CRITICAL CARE BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·June 15, 2011

AMISTEM H FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 22, 2025

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

C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013