15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Absoanchor Microimplant
FDA 510(k)
FDA Class 2
·Dental
Border-Lock® Upper Tray #42
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015806·Dental impression tray, single-use
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
FDA 510(k)
FDA Class 2
·Physical Medicine
AUTO-BAND LIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020
SUPER SECUR-FIT 127 DEGREE SIZE 8
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·September 24, 2019
LINER: CC E CC LIGHT 01.26.2844HCT FLAT PE HC LINER 28 / E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 3, 2021
BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·June 21, 2013
PENUMBRA SYSTEM SEPARATOR FLEX 041
FDA Adverse Event
Malfunction
·PENUMBRA INC.·Product code NRY·July 8, 2011
WALLFLEX ENTERAL DUODENAL STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MUM·September 30, 2008
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 21, 2023
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 21, 2023
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019