9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RANDOX CARBAMAZEPINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040014653·Zirlux 16+ 0M2 55x19x15
BSM BONE SUBSTITUTE MATERIAL
FDA 510(k)
FDA Class 2
·Orthopedic
INTRASTENT DOUBLESTRUT PARAMOUNT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·March 19, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 9, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·March 10, 2008
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
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021