12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517391773·CoRoent® XL Wide, 12x22x50mm
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110867·TIP GUARDS VENTED BLUE PACK OF 100
9000 Series Disposable Channel Cleaning Brush
FDA UDI
Primed Instruments Inc·00666416120383·Cleaning Brush Kit - 9992 Valve and Suction Wel...
CHX=CHX PLUS
FDA 510(k)
FDA Unclassified
·Unknown
RAICHEM MULTI-ANALYTE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CEC·April 23, 2012
12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·July 20, 2017
GEMSTAR PAIN MGE SNG
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 13, 2014
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·January 11, 2013
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·November 23, 2010
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025