14 results · 29ms · Sources: EU EUDAMED, US FDA

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KOWAGENESIS-DF

FDA 510(k)
FDA Class 2 ·Ophthalmic

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450217412·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450225806·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450226094·

REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

FDA 510(k)
FDA Class 2 ·General Hospital

K09-10198 CONVENIENCE KIT

FDA Adverse Event
Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 30, 2009

K09-10198 CONVENIENCE KIT

FDA Adverse Event
Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 30, 2009

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

ACCUTORR PLUS II MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code DXN·April 30, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·September 16, 2014

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·May 12, 2011

SPACER, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

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