13 results
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18ms
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Sources: EU EUDAMED, US FDA
ANESTHESIA BACTERIA FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPIOX® Holders
FDA UDI
Terumo Cardiovascular Systems Corporation·00886799000670·Accessories for SX Oxygenators, holder for CAPI...
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551202029·Retractor, 40 x 10 mm, 22 cm
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209133635·
ACUMED
FDA UDI
Acumed LLC·10806378051654·1.1 mm x 3.5" J-Latch Drill
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022395·FastTrack Effort Interface Kit, Alice6
PIONEER PLUS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 23, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014
MULTIFIX KNOTLESS FIXATION DEVICE
FDA Adverse Event
Malfunction
·ARTHORCARE CORP·Product code MBI·May 26, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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