11 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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MODEL MD-5 DOPPLER
FDA 510(k)
FDA Class 2
·Cardiovascular
Printed Lower Crown Pack for Herbst LR6 8mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015920·
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083014919·Fixed, 10 electrode, MPB, 4-4-4-23-5-5-5-5-5mm ...
TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ECHOCOM, IMAGECOM, DOKUCOM
FDA 510(k)
FDA Class 2
·Cardiovascular
M2A-MAGNUM MOD HD SZ 42MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 30, 2014
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIO·January 8, 2013
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 17, 2010
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
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019