15 results
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19ms
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Sources: EU EUDAMED, US FDA
LIAISON 25 OH VITAMIN D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032844·Baltic Denture System BDLoad Sw6 PLSEbm6DFs A4 ...
SYNTHES RESORBABLE CONTOURABLE MESH
FDA 510(k)
FDA Class 2
·Dental
MAROSIS PACS
FDA 510(k)
FDA Class 2
·Radiology
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
5" (13 CM) APPX 1.8 ML, BAG SPIKE ADAPTER W/CHEMOLOCK¿ W/RED CAP, VENTED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·July 19, 2019
11.0 CM LONG ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NTE·March 29, 2011
OMNIFIT COLLARLESS STEM COCR MOLD#147
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWY·April 22, 2008
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·October 15, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·December 19, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·August 16, 2022
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