13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SCD THERAPEUTIC STOCKING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
FDA 510(k)
FDA Class 2
·Neurology
MODEL 4810 ANALYZER OUTPUT ADAPTER
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #3/11 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·March 22, 2023
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 12, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 16, 2020
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·May 7, 2014
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC·Product code LWR·November 11, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 8, 2013
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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