14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RENOVA INTERNAL HEX IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032774·Baltic Denture System BDLoad Mn6 PLSEbim6DFm A1...
JOSTRA ARTERIAL PERFUSION CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
HRH-63 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 12, 2026
FLEXI-SEAL FMS
FDA Adverse Event
Other
·CONVATEC·Product code KNT·June 7, 2006
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code GEA·March 29, 2013
ADVIA CENTAUR CP TROPONIN ULTRA ASSAY
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·March 29, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·April 23, 2008
FLEXI-SEAL FECAL MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·October 20, 2016
PEEK CAGE, UNKNOWN TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·February 9, 2021
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024