13 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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Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
FDA Recall
Terminated
·Event Medical LTD·Product code CBK·October 13, 2015
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
FDA Enforcement
Class I
·Terminated·Event Medical LTD·November 25, 2015
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·October 31, 2012
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012
Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012
Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012
Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
FDA Recall
Terminated
·Spacelabs Healthcare Inc·Product code DXH·September 3, 2015
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
FDA Recall
Terminated
·Ortho Solutions Inc 330 Franklin Tnpk·Product code HWC·July 14, 2015
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code FMF·July 2, 2012