12 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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BIOLOX DELTA CERAMIC FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
NEPTUNE WASTE MANAGEMENT STSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZAP DUAL CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
DELTA CER FM HD 036/-4MM 12/14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·April 23, 2026
UNKNOWN AVANTAGE HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 6, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
CONSTELLATION
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 4, 2011
RESTORE ADVANCED RECHARGABLE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 28, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 2, 2017
32MM COCR BIOMET FEM HD -3 NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·April 30, 2025
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