18 results
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26ms
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Sources: EU EUDAMED, US FDA
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809868029·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
NA
FDA UDI
Stryker GmbH·00886385005492·Cortical Screw, Non-Lock., Self-tap., T6 Drive
Plateau-LO Spacer System
FDA UDI
Life Spine, Inc.·00190837015657·
8Pin SpO2 Extension Cable for Nellcor Se
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904003818·
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00811801037832·Lateral Disc Cutter, Size 12
K042172
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356405·
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664828857·SpO2 interface cable/Mindray-Oximax/3.0M/314+17...
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
FDA 510(k)
FDA Class 2
·General Hospital
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
FDA 510(k)
FDA Class 2
·Cardiovascular
VECTRA-T-PL 4/4.5 4 SEGMENTS L81 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KWQ·April 9, 2013
INSIGNIA AVT
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 6, 2011
PKG, MIXTER FORCEPS, P/N 0250080249. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018
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