23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The Alma Hybrid Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114315·PUSH-PULL HOOK ANGLED (BX/3)
FLEXCERA BASE
FDA Adverse Event
Malfunction
·ENVISIONTEC GMBH·Product code EBI·November 10, 2021
CASTLE MODEL 233HC STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
PHILIPS MULTIDIAGNOST ELEVA
FDA 510(k)
FDA Class 2
·Radiology
GATTEX
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS AMERICA, INC·Product code FMF·October 10, 2025
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 4, 2025
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 8, 2026
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 29, 2026
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 17, 2008
KAPPA 700 SR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·August 11, 2011
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 2, 2013
BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 28, 2022
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 12, 2025
CUP: MPACT ACETABULAR SHELL Ø60 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·September 7, 2022
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024