12 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SELECTIVE CHARCOAL YEAST EXTRACT AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450182741·
PRISMAFLO II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
FDA 510(k)
FDA Class 2
·Cardiovascular
FEMORAL STEM 12/14 NECK TAPER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 28, 2018
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 9, 2014
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 24, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010
NONE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 26, 2022
NONE
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·August 21, 2022
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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