18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
FDA 510(k)
FDA Class 2
·Ophthalmic
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869621250·MOSS VRS Ti rod, Ø5.5x45mm, straight
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604208·MOSS Ti Rod, Ø5.5x45mm, straight
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351118456·LAP-Insert only, Ø5mm, l=450mm
Endo-s...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351105760·LAP-Instrument, Ø5mm, l=450mm, detach.
Endo-s...
RIVA Posterior Fixation System
FDA UDI
XENIX MEDICAL LLC·00840493415659·Closed Lateral Connector, 45mm
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029929·Bipolar Head Assembly, Size 45mm
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351103612·LAP-Instrument, Ø5mm, l=450mm, flushp.
Endo-s...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351113550·LAP-Instrument, Ø5mm, l=450mm, detach.
Endo-s...
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 30, 2024
BIPOLAR LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 31, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 12, 2011
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012