12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134100·Trial, TLIF, 27L OB STR 7Deg, 10mm
AT HOME DRUG TEST, MODEL 9064
FDA 510(k)
FDA Unclassified
·Unknown
CONCENTRIC RETRIEVER, MODEL 90030
FDA 510(k)
FDA Class 2
·Cardiovascular
28MM M2A HI CARBON HD STD NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 30, 2018
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·April 29, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 10, 2011
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT AG (PRESSATH)·Product code LZS·July 17, 2008
COMP PRIMARY STEM 16MM MINI
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·April 20, 2020
E1 44-41 STD +3 HMRL BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 20, 2020
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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