7 results
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20ms
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Sources: EU EUDAMED, US FDA
Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.
FDA Recall
Terminated
·Orthofix, Inc.·Product code max·February 6, 2012
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
FDA Recall
Terminated
·Synthes, Inc.·Product code MTJ·January 6, 2012
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·June 6, 2012
AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code KRA·February 6, 2012
AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60035 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code KRA·February 6, 2012
AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60040 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code KRA·February 6, 2012
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 21, 2011