20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JUELL SOFT CURE
FDA 510(k)
FDA Class 2
·Dental
Axiom® Uni-Sump
FDA UDI
AXIOM MEDICAL, INCORPORATED·M6651111780·Sump Drain, Two Lumens, Silicone, Large Eye
BiPAP V30 Auto
FDA UDI
Respironics, Inc.·00606959067936·BiPAP V30 Auto, US
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 26, 2004
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO INTEL HEALTH GUIDE PHS6000
FDA 510(k)
FDA Class 2
·Cardiovascular
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
PINN MULTIHOLE W/GRIPTION 54MM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·September 23, 2014
SUPER POLIGRIP/SUPER POLIGRIP ORIGINAL
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·May 26, 2011
BiPAP V30 Auto Ventilator, Part Number 1111178
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code MNS·March 26, 2024
BiPAP V30 Auto Ventilator, Part Number 1111178
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·May 29, 2024
BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNS·April 6, 2021
BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 21, 2021
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 14, 2022
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 14, 2022
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 9, 2025
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021