21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
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
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
LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 23, 2019
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013
APEXPRO TELEMETRY SYSTEM
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·February 25, 2011
CONTAK RENEWAL 3 RF HE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
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
25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016
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
STEM: AMISTEM H HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 5, 2022
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
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