12 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141
FDA 510(k)
FDA Class 2
·Orthopedic
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018
MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017
RAD-8
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 15, 2015
56MM AND R3 ACETABULAR SHELL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016
SIGNATURE PACK, DISPOSABLE TUBING
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQC·May 3, 2013
EXPRESS 4
FDA Adverse Event
Malfunction
·IRIS INTERNATIONAL·Product code JQC·August 21, 2014
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 5, 2011
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