11 results
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57ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
Oticon
FDA UDI
Oticon A/S·05707131347145·OPN PLAY 1, MINIRITE T 312 2.4G C090
ORTHODONTIC CERAMIC BRACKET
FDA 510(k)
FDA Class 2
·Dental
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROMAX-PLUS MOTOR ASSY
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 17, 2014
HX2 TEMPERATURE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·July 11, 2011
AJUST ADJUSTABLE SINGLE INCISION SLING
FDA Adverse Event
Malfunction
·BARD SHANNON LIMITED·Product code FTL·June 14, 2013
COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023
COMPR NANO HMRL PPS 34MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024
COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024
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