16 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STAR/VENT INTERNAL HEX SCREW IMPLANT
FDA 510(k)
FDA Class 2
·Dental
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702367614·ELVAREX 3/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIA...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702248098·Elvarex 2/Thigh High/Slant-Open Toe-Elephantias...
primaLOK SP
FDA UDI
Wenzel Spine, Inc.·00813210021785·primaLOK SP 28mm Medium Boxless Implant, Steril...
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPINNING SPIROS® CLOSED MALE LUER, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025
45MM LEFT STANDARD MANDIBULAR
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code LZD·April 2, 2010
BD SYRINGE 1ML S/T BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 18, 2024
10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·April 29, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 11, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 3, 2011
BD SYRINGE 1ML S/T BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 2, 2024
BD SYRINGE 1ML S/T BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 2, 2024
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