12 results · 19ms · Sources: EU EUDAMED, US FDA

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BD FACSCANTO WITH BD FACSANTO SOFTWARE

FDA 510(k)
FDA Class 2 ·Hematology

HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION

FDA 510(k)
FDA Class 2 ·Anesthesiology

CRYOCARE SURGICAL SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ENDOCARE, CRYOCARE, CRYOPROBE

FDA Adverse Event
Malfunction ·HEALTHTRONICS, INC.·Product code GEH·April 2, 2012

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·November 25, 2025

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·April 8, 2013

EXTENSION, DUAL 4 CHANNEL 10CM

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 29, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 27, 2014

Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 2016

HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

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