17 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VADI MANUAL RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ANATOMIC PEEK PTC Cervical Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169357488·CAGE 5030864 ANATOMIC PTC 16X14X8MM
INTRASTENT DOUBLESTRUT XS STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INJEX 50 SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·March 28, 2013
M2A MAGNUM PF CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 23, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 8, 2008
8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed 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 9, 2010
UNK-AAA
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code MIH·October 30, 2020
UNKNOWN AAA
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code MIH·October 28, 2020
UNKNOWN AAA
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code MIH·October 26, 2020
UNK-AAA
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code MIH·October 26, 2020
UNKNOWN AAA
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code MIH·October 26, 2020
UNKNOWN AAA
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code MIH·October 28, 2020
TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·September 9, 2015
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
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014