19 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198352·AK3 PS Insert Trial Size 5, 18mm
LEONE SPA
FDA UDI
LEONE SPA·08033707065845·EXTRAORAL ELASTICS 3/8" 8 oz
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 3, 2023
RAPIDD HIGHSPEED DENTAL HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 6, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 6, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012