13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
FDA Recall
Terminated
·Cardiac Science, Inc.·Product code MKJ·November 12, 2004
Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
FDA Recall
Terminated
·Cardiac Science, Inc.·Product code MKJ·November 12, 2004
Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
FDA Recall
Terminated
·Cardiac Science, Inc.·Product code NPN·November 12, 2004
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
FDA Recall
Terminated
·Ameda, Inc.·Product code HGY·February 12, 2015
Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.
FDA Recall
Terminated
·Ameda, Inc.·Product code HGY·February 12, 2015
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
FDA Enforcement
Class II
·Terminated·Ameda, Inc.·April 1, 2015
Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.
FDA Enforcement
Class II
·Terminated·Ameda, Inc.·April 1, 2015
Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).
FDA Recall
Terminated
·Medi Manufacturing Inc·Product code ISY·August 11, 2006
Ultrasound probe cover, sterile. Catalog No. 910811.
FDA Recall
Terminated
·North Coast Medi-Tek Inc·Product code KKX·June 7, 2005
Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies
FDA Recall
Terminated
·North Coast Medi-Tek Inc·Product code LOR·May 13, 2011
E-Z-EM brand, Basic biopsy tray, catalog no. 4125.
FDA Recall
Terminated
·North Coast Medi-Tek Inc·Product code LRO·June 23, 2004
SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.
FDA Recall
Terminated
·North Coast Medi-Tek Inc·Product code LRO·January 18, 2005
Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, 3350 North Ridge Avenue, Arlington Heights, IL 60004 USA, Prescription Filled by: AnazaoHealth, 5710 Hoover Blvd., Tampa, FL 33634 USA; product identifier: I125RSRX, model 7000. RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy.
FDA Recall
Terminated
·Medi-Physics Inc. dba GE Healthcare·Product code KXK·September 20, 2011