10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stern Snap One Piece Abutment 1mm Cuff (AE)
FDA UDI
STERNGOLD DENTAL LLC·00841549113802·The SternSnap Attachment is indicated for use w...
SwishPlant® Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307105923·4.8mmD x 6mmL, 4.8mmD Platform
Swish™ Implant Analog
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307120612·
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SUCTION ORA-SWAB(R) BRUSH KIT
FDA 510(k)
FDA Class 1
·Dental
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 9, 2013
IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·November 22, 2010
INCEPTA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 18, 2015