13 results
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21ms
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Sources: EU EUDAMED, US FDA
ZOLL SUREPOWER SINGLE BAY CHARGER
FDA 510(k)
FDA Class 3
·Cardiovascular
ArgenZ HT+ 98x30 A1
FDA UDI
ARGEN CORPORATION, THE·D818122839·Dental porcelain/ceramic restoration kit
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970546·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970553·
PRADO™ Lumbar Interbody Fusion System
FDA UDI
Pt. Solutions, LLC·G616RAFS122839060·NON-STERILE PLANAR, PRADO A SYMMETRIC PEEK IBFD...
SPIDER STANDARD AND ADVANCED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TARGET DEVICE 300X160MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 2, 2012
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·May 21, 2013
ARROWGARD BLUE PLUS QUAD-LUMEN CVC KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL·Product code DQY·June 8, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 14, 2008
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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024