18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BCI WW1030 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
QUADRA BROACH SIZE 0
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012
BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·April 29, 2013
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·May 10, 2011
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH , LTD./HUNTINGTON·Product code MFK·July 25, 2008
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 11, 2019
LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 25, 2019
LINER: MPACT FLAT PE HC LINER 36/ER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 17, 2020
MPACT LINER FLAT PE HC LINER Ø 32/D
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 5, 2016
INFOV.A.C. THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·March 4, 2021
CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 17, 2022
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018