9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LASERSAFE PERSONNEL AND PATIENT SHIELDS
FDA 510(k)
FDA Class 1
·Anesthesiology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209112081·KIT, RESCUE TASK FORCE CHEST POUCH - PH3 - COY
STERLING INTERFERENC SCREW HT
FDA 510(k)
FDA Class 2
·Orthopedic
IBL 5000 Tanning Booth
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 5, 2014
XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code MNI·November 27, 2012
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·September 28, 2010
Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 13, 2014
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013