11 results
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25ms
·
Sources: EU EUDAMED, US FDA
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
30DEG SMOOTH ELEVATOR RASP
FDA UDI
Biomet Orthopedics, LLC·00880304474710·
Stern Snap One Piece Abutment 4mm Cuff (AK)
FDA UDI
STERNGOLD DENTAL LLC·00841549113758·The SternSnap Attachment is indicated for use w...
Smooth Elevator Rasp
FDA UDI
Biomet Orthopedics, LLC·00887868567650·
Swish™ Cover Screw
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307115748·
LATEX PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·November 22, 2010
LIBERTÉ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·January 9, 2013
SELUTE PICOTIP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 1, 2014
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015