18 results · 22ms · Sources: EU EUDAMED, US FDA

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MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

Safco polycarbonate crowns

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310223473·Safco polycarbonate crowns #53 5/box

COOLTOUCH II

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

TRANSEND GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010

CONTOUR TEST STRIPS

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·May 25, 2012

CONTOUR

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 8, 2013

TRANSEND GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·November 9, 2010

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 17, 2011

PRECISION XTRA / OPTIUM

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 27, 2008

TRANSEND GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 13, 2013

I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026