6 results
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45ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional laser handpiece when purchased separately), Subassembly (unit only, no safety glasses, owner's manual, etc. included); 2.) 404207 Completed unit (safety glasses, owner's manual, etc. included), glossy finish, 220 Volt; 3.) 404207-MP Completed unit, matte finish, 220 Volt, Multi-Platform configuration; 4.) 404207-B Completed unit, matte finish, 220 Volt; 5.) 404207-USAB Completed unit, matte finish, 220 Volt, USA-style power cord; 6.) 404208-B Completed unit, matte finish, 110 Volt; and 7.) 404208-MP Completed unit, matte finish, 110 Volt, Multi-Platform configuration. The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
FDA Recall
Terminated
·Sybaritic, Inc·Product code GEX·April 12, 2008
Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
FDA Enforcement
Class I
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·November 28, 2012
Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
FDA Enforcement
Class I
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·November 28, 2012
Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
FDA Recall
Terminated
·Mindray DS USA, Inc., dba Datascope Patient Monitoring·Product code BSZ·March 5, 2010
Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
FDA Recall
Terminated
·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code BSZ·August 13, 2012
Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
FDA Recall
Terminated
·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code BSZ·August 13, 2012