23 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPAL-RAD
FDA 510(k)
FDA Class 2
·Radiology
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
FDA 510(k)
FDA Class 1
·Ophthalmic
HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STELLARIS VISION ENHANCEMENT SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·February 5, 2026
VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·November 15, 2017
VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·June 22, 2018
AMISTEM H, HA COATED STEM SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 9, 2017
LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 52/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 9, 2021
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 15, 2024
STELLARIS ELITE VISION ENHANCEMENT SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·March 1, 2022
LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 23, 2019
ARIS TRANS-OBTURATOR SLING
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code OTN·November 6, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 17, 2013
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·June 19, 2008
PRIME 5TH WHEEL STRETCHER, 26"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 11, 2011
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 29, 2023
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·October 16, 2020
STELLARIS POWER SUPPLY II
FDA Adverse Event
Malfunction
·BAUSCH + LOMB·Product code HQC·August 1, 2023
QUADRA S FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 6, 2025
VERSAFITCUP DM ACETABULAR SHELL Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 24, 2015