13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEPCON/SYSTEM RC-10
FDA 510(k)
FDA Class 2
·Hematology
Preat
FDA UDI
Preat Corporation·00842092172568·2.5mm Retention Caps--Light Green (6-Pack)
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117400884·
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408500·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306809682·Double Luer Lock Handle
LeadCare® II Blood Lead Testing System 9X ClinicalTest Kit
FDA UDI
MAGELLAN DIAGNOSTICS, INC.·00850355006109·LeadCare® II Blood Lead Testing System 9X Clini...
PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 23, 1998
3MP Monochrome Digital Mammography LCD Monitor MS-S300
FDA 510(k)
FDA Class 2
·Radiology
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AXIUM PLATINUM 3-D DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·May 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021