16 results
·
40ms
·
Sources: EU EUDAMED, US FDA
LENSX 550 LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 19, 2025
BD SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 9, 2021
BIOMOL ASPIRATION BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMARTFLOW
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 23, 2024
STANDARD INSERT
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·July 3, 2012
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCAITES·Product code MIH·April 23, 2013
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·May 10, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Other
·INSULET CORPORATION·Product code LZG·July 25, 2008
BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 10, 2021
52MM METAL ON METAL SHELL
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·July 3, 2012
ULT*TAPER POLISHED STEM SZ 0
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code JDI·July 3, 2012
HIP HEAD 10/12 TAPER 28+0 M
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWY·July 3, 2012
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