14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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