20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
FDA 510(k)
FDA Class 1
·Microbiology
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 26, 2020
VIDAS TSH
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 25, 2020
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JHI·August 19, 2021
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515017269·Vascular Forceps, Serr, Cvd Jaws, 6 1/2"
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351109133·LAP-Instrument, Ø5mm, l=330mm, flushp.
Graspi...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351110993·LAP-Instrument, Ø5mm, l=330mm, detach.
Graspi...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351102929·LAP-Instrument, Ø5mm, l=330mm, flushp.
Graspi...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351117763·LAP-Insert only, Ø5mm, l=330mm
Graspi...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351115462·LAP-Instrument, Ø5mm, l=330mm, detach.
Graspi...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351112867·LAP-Instrument, Ø5mm, l=330mm, detach.
Graspi...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351105081·LAP-Instrument, Ø5mm, l=330mm, detach.
Graspi...
SENSOMETRICS SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DURASUL®, ALPHA INSERT, HOODED, II/32
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·November 4, 2025
NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·August 26, 2024
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·October 3, 2014
UNK DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 3, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 22, 2011
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026