18 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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