96 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
FDA Enforcement
Class II
·Ongoing·Draeger Medical, Inc.·October 20, 2021
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B IT2110X21B JP2100X16B JP2110X16B KR2110X15B LA2100X15B LA2110X15B ND2110X15B RDE2100X13B RDE2110X13B RDS2110X11B RIN2100X15B RIN2110X15B RJP2100X16B RJP2110X16B UDS2110X11B
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·January 10, 2024
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·April 10, 2024
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·April 10, 2024
Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·April 10, 2024
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiopulmonary Gmbh·August 6, 2025
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
FDA Enforcement
Class II
·Ongoing·Human Care Hc Sweden Ab·April 17, 2024
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
FDA Enforcement
Class II
·Ongoing·Keystone Industries·January 10, 2024
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·November 20, 2024
Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·November 20, 2024
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·November 20, 2024
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·November 20, 2024
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006
FDA Enforcement
Class II
·Ongoing·Belmont Instrument LLC·February 12, 2025
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS
FDA Enforcement
Class II
·Ongoing·Philips North America LLC·April 13, 2022
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
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·November 20, 2024
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·November 20, 2024
Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·November 20, 2024
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·February 2, 2022
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 9, 2025