14 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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IMMULITE® 2000 Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)
Tissue Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A202826150·20mm H x 28mm W x 26mm L x 15 degrees
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A202826120·20mm H x 28mm W x 26mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A20282680·20mm H x 28mm W x 26mm L x 8 degrees ALIF
EQUITY
FDA 510(k)
FDA Class 2
·Dental
CLEAR-IT ANTI-FOG, MODEL PS003
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNK
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·October 17, 2008
ATLANTIS¿ SR PRO²
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT·Product code DQO·August 11, 2011
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 2, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021