10 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011
Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949 Circumcision Clamp
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
FDA Recall
Terminated
·Medtronic, Inc. Neuromodulation·Product code LKK·July 5, 2011
Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXL·December 14, 2010
Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXL·December 14, 2010
Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety surgical and non-surgical applications including; cerebral, thoracic, abdominal, peripheral, orthopedic, cardiac, and vascular procedures.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IZL·December 14, 2010
Synchron LX20, Part Number: 466200. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·April 5, 2011
Synchron LX20 PRO, Part Number: 476100. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·April 5, 2011
Synchron LXi 725, Part Number: 476501. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·April 5, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012