15 results · 20ms · Sources: EU EUDAMED, US FDA

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SYNGO.PET&CT ONCOLOGY

FDA 510(k)
FDA Class 2 ·Radiology

ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100

FDA 510(k)
FDA Class 2 ·General Hospital

COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

FDA Adverse Event
Injury ·NITI MEDICAL TECHNOLOGIES LTD.·Product code FZP·September 2, 2011

COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

FDA Adverse Event
Injury ·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011

CQUR MESH

FDA Adverse Event
Injury ·ATRIUM MEDICAL CORP.·Product code FTL·May 1, 2013

SINGLE EXTENSION

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·May 12, 2011

BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 31, 2019

Q-SYTE CLOSED LUER ACCESS DEVICE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·November 13, 2020

BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 8, 2022

BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 7, 2018

INNOVANCE D-DIMER

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code DAP·July 14, 2017

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·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