13 results
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20ms
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Sources: EU EUDAMED, US FDA
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Philips
FDA UDI
Sbo Hearing A/S·05714464091362·HEARLINK 1700 BTE PP TP
ELMED
FDA UDI
ELMED INCORPORATED·00842180136335·5MM, 33CM NEEDLE HOLDER, CURVED LEFT TUNGSTEN C...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776209117·LAP NH CVD LEFT TUNGSTEN CARBIDE TIP
LEONE IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Straumann TLX Implant System
FDA 510(k)
FDA Class 2
·Dental
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 3, 2023
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 3, 2023
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2014
ASR UNI FEMORAL IMPLANT SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 16, 2011
SMALL CLIP APPLIER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 26, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013