15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES LCP DISTAL TIBIA PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
Sharper Image
FDA UDI
Merchsource, LLC·00843479136043·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132080·Trial, TLIF, 27L OB CRV 7Deg, 8mm
STEVE MADDEN
FDA UDI
FGX INTERNATIONAL INC.·00193033471296·
CW DISPOSABLE ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
FDA 510(k)
FDA Class 2
·Cardiovascular
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 8, 2021
3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code OVE·March 20, 2013
CHARITE SIZE 3 ENDPLATE, 0-DEGREE
FDA Adverse Event
Injury
·DEPUY SPINE INC.·Product code MJO·March 8, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 12, 2008
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·May 5, 2016
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·July 20, 2016
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014