510(k) Premarket Notification | 合法醫療器材資訊網

Device Name, Date. Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results, 07/07/21. Medtronic Vascular Recalls Angiographic ... Read More

2021年4月12日 — The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More

2021年7月2日 — Medtronic Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile ... The FDA has identified this as a Class I recall, the most ... Read More

Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues, 11/03/20. Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump ... Read More

June 3, 2021. The U.S. Food and Drug Administration (FDA) is alerting health care providers that Medtronic has stopped the sale and distribution of the ... Read More

2021年4月9日 — The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More

2021年6月3日 — FDA is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic's Heartware Ventricular Assist ... Read More

Results 1 - 10 of 17 — used to interrogate cardiac implantable electronic devi...15, 2, 04/30/2021, Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). CRT- ... Read More

Results 1 - 10 of 13 — ProductCode: LZG Applicant: MEDTRONIC MINIMED Decision Date To: 07/07/ ... medtronic minimed paradigm insulin pump, models mmt-515 and ... Read More

Super Search Devices@FDA ... APPROVAL FOR THE MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY WHICH INCLUDES THE MODEL 3387 DBS LEAD, MODEL 3389 DBS LEAD, ... Read More