28 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NewPrim System
FDA 510(k)
FDA Class 2
·Orthopedic
Medline
FDA UDI
MEDLINE INDUSTRIES, INC.·10889942144396·PACK ARTHROGRAM
Oticon
FDA UDI
Oticon A/S·05707131340177·SIYA 2, KIT 312 NFM 85 R C001
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
FDA 510(k)
FDA Class 2
·Ophthalmic
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
FDA 510(k)
FDA Class 2
·Cardiovascular
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 19, 2020
LADARVISION 4000 LASER
FDA Adverse Event
Malfunction
·ALCON-ORLANDO TECHNOLOGY CENTER·Product code LZS·October 1, 2008
CELL-DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 4, 2011
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013
LINER: MPACT FLAT PE HC LINER 36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 27, 2021
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 20, 2025
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
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 17, 2025
STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 10
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 15, 2021
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
MPACT 3D METAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 29, 2026
CD HORIZON ASTUTE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code NQP·April 16, 2021
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 5, 2026
LINER: MPACT FLAT PE HC LINER Ø36/F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 13, 2023
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 6, 2025