10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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M3 MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032836·Baltic Denture System BDLoad Ln6 PLSEbil2DFl A4...
MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TIPSTOP US
FDA Adverse Event
Injury
·PLASTO TECHNOLOGIES·Product code KMF·March 1, 2013
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·March 29, 2011
GORE VIABAHN ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC.·Product code NIP·April 22, 2008
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
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025