16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lucent XP, Lucent XP Curved
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)
SUPER 1
FDA 510(k)
FDA Class 2
·Dental
I-STETHOS LINK
FDA 510(k)
FDA Class 2
·Cardiovascular
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 16, 2022
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 5, 2022
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 2, 2023
TENDRILL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 2, 2011
HICKMAN, TRIFUSION
FDA Adverse Event
BARD ACCESS SYSTEMS, INC.·Product code LJS·June 26, 2013
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·February 23, 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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025