97 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
FDA Recall
Terminated
·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011
MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
FDA Recall
Terminated
·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011
MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
FDA Recall
Terminated
·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011
MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
FDA Recall
Terminated
·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011
MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
FDA Recall
Terminated
·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011
MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
FDA Recall
Terminated
·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011
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
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
GE Carestation 30 anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
GE 9100c NXT anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
FDA Recall
Terminated
·BrosMed Medical Co., Ltd. Bubugaogaofu Lou Lou 15th Songshan Lake Hi Dongguan China·Product code LIT·December 14, 2018