54 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·December 18, 2008
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·September 28, 2016
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Viewray Incorporated·October 21, 2015
Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
FDA Recall
Terminated
·Cti Pet Systems Inc·Product code KPS·October 2, 2003
PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x 48'' and 6''x 48''Single Ply and 4''x 4 YDS, 6''x 4 YDS and 3''x 4YDS, 1/pk 25 pk/cs, Manufactured for: Professional Hospital Supply, 41980 Winchester Rd, Temecula, CA 92590.
FDA Recall
Terminated
·Rx Textiles Inc·Product code :·June 11, 2003
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
FDA Recall
Terminated
·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code CAZ·August 24, 2016
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.
FDA Enforcement
Class I
·Terminated·Western / Scott Fetzer Company·July 29, 2015
MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Terminated
·Viewray Incorporated·Product code IYE·August 27, 2015
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
FDA Recall
Terminated
·Product code GAM·June 6, 2007
CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018