13 results
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36ms
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Sources: EU EUDAMED, US FDA
BIPAP PRO 2 BI-LEVEL SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032834·Baltic Denture System BDLoad Mw7 PLSEbim6DFm A4...
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PORTA GEO TI MODEL #2004
FDA 510(k)
FDA Class 2
·Dental
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
FLEXI-SEAL FMS
FDA Adverse Event
Other
·CONVATEC·Product code KNT·June 7, 2006
BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE
FDA Adverse Event
Injury
·ACUTE INNOVATIONS·Product code HRS·February 22, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 29, 2011
G2 FILTER SYSTEM, JUGULAR
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·April 22, 2008
FLEXI-SEAL FECAL MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·October 20, 2016
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