14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TDM Screw Systems
FDA 510(k)
FDA Class 2
·Orthopedic
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019
VADER pedicle system, torque wrench, Catalog Number 42-702
FDA Enforcement
Class II
·Ongoing·Icotec Ag·January 17, 2024
EM ENT STRAIGHT SUCTION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·December 13, 2024
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·June 26, 2019
PASSIVE PLANAR BLUNT PROBE
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·December 13, 2024
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
STERLING MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code DQY·September 24, 2008
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 25, 2018
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018