15 results · 23ms · Sources: EU EUDAMED, 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