9 results · 21ms · Sources: EU EUDAMED, 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