32 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OR3O Dual Mobility System
FDA 510(k)
FDA Class 2
·Orthopedic
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LPH·October 17, 2025
BD BBL™ Middlebrook and Cohn 7H10 Agar Slants
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902209592·BD BBL™ Middlebrook and Cohn 7H10 Agar Slants, ...
priti®multibloc ZrO2
FDA UDI
Pritidenta GmbH·04251366905355·
Tizian Block 5.0
FDA UDI
Pritidenta GmbH·04251366906406·
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
FDA 510(k)
FDA Class 2
·Microbiology
GLO-SPEC I, II AND III
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 28, 2026
COCR HEAD 28/+4 'L' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code MEH·January 26, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·May 4, 2026
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·August 23, 2011
FORTIFY ASSURA VR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·November 3, 2014
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 3, 2013
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 2, 2026
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
FDA Enforcement
Class II
·Terminated·Karl Storz Endoscopy·September 4, 2019
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 30, 2025
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·March 17, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·March 17, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·November 3, 2025
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·May 21, 2025