10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BONART ART-L5 LED CORDLESS CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
MTG - MINITUB HEATED STAGE SYSTEMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ISOLA SPINAL SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,DOM
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 18, 2022
MINICAP TRANSFER SET
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 29, 2013
UNKNOWN LONGEVITY LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·May 3, 2011
SOEHENDRA LITHOTRIPSY CABLE
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code LQC·July 25, 2008
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017
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