15 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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V FACTOR DISCS
FDA 510(k)
FDA Class 1
·Microbiology
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18025011·
36M - City of Gastonia - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588025018·36M - City of Gastonia - Metal
FacetLINK MI
FDA UDI
LINKSPINE, INC.·00817329024460·Dilator 1
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277114372·Nordt Micro Fracture 20 Degree Awl
Quantib Prostate
FDA 510(k)
FDA Class 2
·Radiology
PFIZER/AS&E 0450 LOCALIZER
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 9, 2014
*
FDA Adverse Event
Malfunction
·KARL STORZ ENDOSCOPY·Product code FED·September 24, 2012
ANTI-REFLEC Y-SET 8"
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code ---·August 17, 2010
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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