13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRAFTGUARD PRESSURE CONTROLLING SYRINGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HairCheck-DT (Opiates)
FDA UDI
Quest Diagnostics·00868586000223·HairCheck-DT (Opiates) is an ELISA test kit use...
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127053·
MICROPAQ, MODELS 402 AND 404
FDA 510(k)
FDA Class 2
·Cardiovascular
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNSPECIFIED BD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·February 11, 2019
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·July 12, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·April 28, 2011
TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION LINER IMPACTOR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·July 23, 2008
CORIN METAFIX HIP STEM
FDA Adverse Event
Injury
·CORIN MEDICAL·Product code LZO·September 6, 2022
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