11 results · 19ms · Sources: EU EUDAMED, US FDA

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QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA

FDA 510(k)
FDA Class 2 ·Immunology

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450376126·

RANDOX CARBAMAZEPINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

INTRASTENT DOUBLESTRUT PARAMOUNT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TI 12-POINT NUT-11MM

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code NKB·March 26, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 21, 2011

CAPSURE EPI

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code DTB·March 31, 2008

ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 58/LL

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWA·July 24, 2020

1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

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