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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications
FDA Enforcement
Class II
·Terminated·Hitachi Aloka Medical, Ltd.·April 5, 2017
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 4, 2012
Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3.5mm x 19cm Reference Number: 100/111/035
FDA Recall
Terminated
·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003
Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3mm x 17cm Reference Number: 100/111/030
FDA Recall
Terminated
·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003
Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQO·April 15, 2008
Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 8mm x 33cm Reference Number: 100/111/080
FDA Recall
Terminated
·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003
Portex Uncuffed Oral Tracheal Tubes, Siliconized 6mm x 19cm Reference Number: 100/126/060
FDA Recall
Terminated
·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003
Portex Uncuffed Nasal Tracheal Tubes, Ivory 5mm x 25cm Reference Number: 100/105/050
FDA Recall
Terminated
·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003
Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised 5 mm x 25cm Reference Number: 100/141/050
FDA Recall
Terminated
·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003
Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQO·April 15, 2008
Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5 mmx 25cm Reference Number: 100/179/050
FDA Recall
Terminated
·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003
Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQO·April 15, 2008
Portex Uncuffed Oral/Nasal Tracheal Tube, Murphy Eye Clear 3.5 mm x 19cm Reference Number: 100/127/035
FDA Recall
Terminated
·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003
Portex Profile Soft-Seal Cuff Oral/Nasal Tracheal Tube, Clear Murphy Eye 8 mm x 33cm Reference Number: 100/199/080
FDA Recall
Terminated
·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code FPA·January 13, 2017
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
FDA Recall
Terminated
·Arthrex, Inc.·Product code HRS·January 11, 2016
12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·July 9, 2008
12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·July 9, 2008
10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·July 9, 2008
Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications
FDA Recall
Terminated
·Hitachi Aloka Medical, Ltd.·Product code IYN·June 11, 2014