14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SONIC SHOT GX
FDA 510(k)
FDA Class 2
·Cardiovascular
BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·July 2, 2019
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
FDA 510(k)
FDA Class 2
·Cardiovascular
FOGARTY VALVULOTOME, MODEL 700091
FDA 510(k)
FDA Class 2
·Cardiovascular
21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 28, 2017
SYRINGE 1ML LS 200 S/C
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 4, 2019
SYRINGE 1ML ST BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 15, 2019
21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO., (BD)·Product code FMI·September 6, 2016
VOYAGER RX CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·February 5, 2008
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·September 16, 2014
INTACT HUMAN CHORIONIC GONADOTROPIN + THE BETA-SUBUNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DHA·May 17, 2011
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
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