11 results
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20ms
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Sources: EU EUDAMED, US FDA
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
FDA 510(k)
FDA Class 2
·Cardiovascular
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761976085·Trumpf Medical/Medizin Pad TTS 130 G
Pads
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761969032·Pad TTS 130 G
WAVEWRITER ALPHA PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 4, 2025
ADVIA RETIC PLUS
FDA 510(k)
FDA Class 2
·Hematology
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·April 26, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 6, 2011
PROXIMATE RELOADABLE VASCULAR LINEAR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 24, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014