13 results · 23ms · Sources: EU EUDAMED, US FDA

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R&D CBC-3D + CRP HEMATOLOGY CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

SOAR Retractor System

FDA UDI
SPINEOLOGY INC.·M7603061511·15mm x 110mm Portal Tube

O-LAS OPHTHALMIC PHOTODISRUPTOR

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

CYTOFLEX MESH

FDA 510(k)
FDA Class 2 ·Dental

145-DEG PE 40MM HUM LINER +2.5

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·November 12, 2024

TOTALCARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 27, 2013

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN BENNETT CORP.·Product code CBK·March 16, 2011

SILICONE ADVANCED OPTIC-VIOLET SHIELD

FDA Adverse Event
Malfunction ·BAUSCH & LOMB·Product code HQL·June 17, 2008

DYNESYS LIS, STABILIZING CORD, 200

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code NQP·May 2, 2019

REVIVE - THROMBECTOMY DEVICE

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code DXE·January 29, 2016

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018