11 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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Access Folate Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLOBAL CAP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105565·GLOBAL C.A.P. CTA CTA PIN 2.4 X 42mm
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
FDA 510(k)
FDA Class 1
·General Hospital
ACROBAT CALIBRATED TIP WIRE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code OCY·August 5, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 12, 2013
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
FDA Recall
Open, Classified
·Prismatik Dentalcraft, Inc.·Product code NHA·September 30, 2025
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026