12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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X-cera Pre-shaded Zirconia Blanks
FDA 510(k)
FDA Class 2
·Dental
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112588·BARRON CORNEAL PUNCH 6.75MM
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
EZ-COMFORT TRANSPORTER 2000 SERIES
FDA 510(k)
FDA Class 1
·Physical Medicine
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·April 16, 2026
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022
PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 27, 2014
CT9000 ADV 115V/220V W/PED. +OB
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code DXT·August 8, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 2, 2013
CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021