Panels › Anesthesiology › Product code BSZ · Class 2
Gas-Machine, Anesthesia
Regulation 868.5160
2510(k)s in 12 months (189 all time)
12recalls in 12 months (177 all time)
161recalls that name a 510(k)
Top companies in BSZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2010 | Ge Healthcare, Llc GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor Terminated |
BSZ | K090233 |
| Apr 16, 2010 | Blease Medical Equipment, Ltd. The BleaseSirius and BleaseFocus Anaesthesia Systems. Terminated |
BSZ | K051629 |
| Apr 8, 2010 | Mindray DS USA, Inc., dba Datascope Patient Monitoring 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 au Terminated |
BSZ | K080175 |
| Jul 30, 2009 | GE Healthcare Datex-Ohmeda S/5 Anesthesia Delivery Unit
Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure su Terminated |
BSZ | K042154 K050676 +1 |
| Jul 30, 2009 | GE Healthcare Datex-Ohmeda AS/3 Anesthesia Delivery Unit
An Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated fo Terminated |
BSZ | K042154 K050676 +1 |
| Jul 30, 2009 | GE Healthcare GE Datex-Ohmeda ADU Carestation
Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. Terminated |
BSZ | K042154 K050676 +1 |
| Jun 23, 2009 | GE Healthcare GE Datex-Ohmeda Advance Anesthesia Gas-Machine. Terminated |
BSZ | K081844 |
| Jun 23, 2009 | GE Healthcare GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine. Terminated |
BSZ | K073707 |
| Dec 5, 2008 | Mindray DS USA, Inc., dba Datascope Patient Monitoring AS3000 Anesthesia Delivery System. Datascope Patient Monitoring;
A Mindray Global Company.
The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalatio Terminated |
BSZ | K080175 |
| Oct 8, 2008 | Draeger Medical, Inc. Draeger Medical Apollo Anesthesia Machine, catalog number 8606500 Terminated |
BSZ | K042607 |
| Oct 6, 2008 | Datex - Ohmeda, Inc GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550
Datex-Ohmeda Aisys
Intended to provide ge Terminated |
BSZ | K073707 |
| Sep 23, 2008 | Draeger Medical, Inc. Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation. Terminated |
BSZ | K042419 |
| Jul 16, 2008 | Draeger Medical, Inc. Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969. Terminated |
BSZ | K042419 |
| Sep 7, 2007 | MAQUET Inc. Kion Anesthesia Workstation
Maquet Critical Care AB
SE-171-95 Solna, Sweden Terminated |
BSZ | None listed |
| Dec 19, 2006 | Datex - Ohmeda, Inc Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finlan Terminated |
BSZ | K973985 |
| Nov 7, 2006 | Datex - Ohmeda, Inc GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company Terminated |
BSZ | K061609 |
| Oct 19, 2006 | Draeger Medical, Inc. Fabius GS Anesthesia Machine. Catalog number 8604699 Terminated |
BSZ | K042419 |
| Jul 12, 2006 | GE Healthcare Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The deliver Terminated |
BSZ | K973985 |
| Jun 2, 2006 | Datascope Corp Anestar and Anestar Plus Anesthesia System. Terminated |
BSZ | K001988 |
| May 9, 2006 | GE Healthcare Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) Terminated |
BSZ | K973985 |
| Oct 12, 2005 | Datex-Ohmeda Inc Datex-Ohmeda Aespire Carestation. This device is not marketed in the US. Terminated |
BSZ | None listed |
| Oct 12, 2005 | Datex-Ohmeda Inc Datex-Ohmeda S/5 Aespire Anesthesia System 7900 Terminated |
BSZ | K050626 |
| Oct 12, 2005 | Datex-Ohmeda Inc Datex-Ohmeda S/5 Aespire Anesthesia System 7100 Terminated |
BSZ | K000706 |
| Nov 11, 2004 | Draeger Medical, Inc. APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines. Terminated |
BSZ | K033498 K041266 |
| Sep 9, 2004 | Datascope Corp Anestar Anesthesia Delivery System Terminated |
BSZ | None listed |
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units
(The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly Terminated |
BSZ | K973985 |
| Aug 28, 2003 | Datex-Ohmeda Inc Datex-Ohmeda S/5 Anesthesia Delivery Units Terminated |
BSZ | K973985 |
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