15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAS INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
Mapleson Anesthesia Breathing Circuit
FDA UDI
MERCURY ENTERPRISES, INC.·10641043803806·
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JKA·July 6, 2022
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 19, 2022
FOTOMASTER
FDA 510(k)
FDA Class 2
·Radiology
MP3HD BIG BOY, POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 19, 2019
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 19, 2019
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·April 26, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 6, 2011
ACUVUE ADVANCE FOR ASTIGMATISM
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·July 21, 2008
HARMONIC SCALPEL CURVED SHEARS
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 27, 2019
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·August 29, 2019
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015