11 results
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18ms
·
Sources: EU EUDAMED, US FDA
SR-IV PROGRAMMED SUBJECTIVE REFRACTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
Porcine Mineral Collagen Composite
FDA 510(k)
FDA Class 2
·Dental
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
FDA 510(k)
FDA Class 2
·Anesthesiology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 23, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS SLC·Product code JAA·December 30, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURING FACILITY·Product code KDJ·August 17, 2010
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025