14 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMS AIR-FLOW MASTER PIEZON
FDA 510(k)
FDA Class 2
·Dental
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780025290·Integra® Jarit® Knife Handle, # 4L, 8-1/4", For...
NA
FDA UDI
MAKO SURGICAL CORP.·00848486002602·Straight Hex Driver 100mm Length
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
POWERPACK
FDA Adverse Event
Malfunction
·ICC-NEXERGY·Product code IYN·September 3, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2014
ROD FOR STRAIGHT CUP HOLDER
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code LXH·May 19, 2011
3.2MM Pellet Insertion Tray Catalog Number: B1144
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 24, 2024
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024