23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517635556·CoRoent Ant TLIF PEEK, 10x11x34mm 15°
OrthoMedFlex, LLC
FDA UDI
ORTHOMEDFLEX LLC·M7161013450·Femoral Rasp
tremoFlo US Software
FDA UDI
Thorasys Thoracic Medical Systems Inc·07540261013454·tremoFlo Airwave Oscillometry System software c...
WIRE SPECULUM
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896089723·WIRE SPECULUM MINIATURE CLOSED WIRE BLADES
Indus
FDA UDI
SPINEFRONTIER, INC.·00190361035541·Indus Invue MAX Symmetrical ACP, 2 Level, 45mm
ZAVATION
FDA UDI
Zavation LLC·00842166118218·Hook Trial, 4.5mm
Latch Reamer
FDA UDI
BICON, LLC·00813110024336·4.5mm Extended Latch Reamer
Zavation
FDA UDI
Zavation LLC·00197157010003·4.5mm TAP, CANNULATED, NAVLOCK
SYSTEMS INTEGRATION MODEL: ENDOALPHA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
STELLARIS VISION ENHANCEMENT SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·February 5, 2026
VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 11, 2022
ESSURE
FDA Adverse Event
CONCEPTUS·Product code HHS·May 3, 2013
LINOX SD 65/16
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code LWS·August 5, 2008
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2011
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016
VITROS ECI IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·February 2, 2016
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016