18 results · 29ms · Sources: EU EUDAMED, US FDA

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AXIR-CX

FDA 510(k)
FDA Class 2 ·Radiology

OsteoMed

FDA UDI
OSTEOMED LLC·00845694020329·FPS 3.5mm x 20mm Standard Screw

Best Medical International

FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365115868·

Votion

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730007834·Votion 018 MC LR5 G/O -17T 2A 0O (10PK)

Votion®

FDA UDI
Ortho Organizers, Inc.·00190707113520·Votion .018 MC LR5 G/O -17T 2A 0O (10PK) VOTION

OsteoMed

FDA UDI
OSTEOMED LLC·00845694074360·FPS 3.5 x 20mm Screw Sterile Qty 2

MAMMOMAT INSPIRATION PRIME

FDA 510(k)
FDA Class 2 ·Radiology

SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

M2A-MAGNUM PF CUP 54ODX48ID

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 13, 2018

M2A MAGNUM 42-50M TPR INSRT +6

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 13, 2018

TAPERLOC POR FMRL LAT 10X140

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 13, 2018

ENSITE CLASSIC SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·ANIMAS CORP.·Product code LZG·October 27, 2008

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2011

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

FDA Enforcement
Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

DRX Revolution Mobile X-Ray System

FDA Enforcement
Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021