12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITAL SIGNS PEEP VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112564·BARRON CORNEAL PUNCH 6.0MM
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776123925·Bipolar Forcep, Angled Down 45 degrees,
Portex
FDA UDI
ICU MEDICAL, INC.·15019517076851·
BIOLOK SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
NUVASIVE LATERAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PLUM A+ (11.3 VERSIO
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 23, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024