13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SKINCLEAR Q-SWITCHED ND:YAG LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FLO-BOOT
FDA 510(k)
FDA Class 1
·Physical Medicine
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 29, 2013
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 29, 2008
RESERVOIR 3CC
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 13, 2011
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 2, 2023
BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 2, 2023
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