16 results
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27ms
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Sources: EU EUDAMED, US FDA
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Due to the open design of the system, the Signa 0.7T Signa OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles. . .
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032795·Baltic Denture System BDLoad ↓ Mn7 PLSEum2DFm A...
CombiSet
FDA UDI
Fresenius Medical Care Holdings, Inc.·00840861100477·Pre-pump, 8.0 mm, BVM
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
FDA 510(k)
FDA Class 2
·Anesthesiology
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BAG SPIKE W/CLAVE, DRY SPIKE ADAPTER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·August 13, 2015
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
NKS PM-L
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 3, 2013
PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 29, 2011
CLARION
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·April 23, 2008
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code FJK·November 19, 2010
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024