27 results
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7ms
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Sources: EU EUDAMED, US FDA
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view
FDA Enforcement
Class II
·Ongoing·Haag-Streit USA Inc·December 30, 2020
Veradius Unity Mobile Surgery C-arm
FDA Enforcement
Class II
·Ongoing·Philips North America·November 15, 2023
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity , Neo/Inf Intub CO2 Line LTerm Lng , VitaLine H Set Adult/Pediatric , VitaLine H Set Infant/Neonatal , FilterLine Set Long Adult/Pediatric , FilterLine H Set Long Adult/Pediatric , FilterLine H Set Long Infant/Neonatal , Trade Compliant: FilterLine H, Adult/Ped , Trade Compliant: FilterLine H, Infant/Neo , FilterLine Set Adult/Pedi , FilterLine H Set Adult/Pedi and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 14, 2025
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI).
FDA Enforcement
Class II
·Ongoing·NeuroSync, Inc.·July 23, 2025
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
FDA Enforcement
Class II
·Ongoing·Delta Med SpA·August 25, 2021
NEO DELTA Self Safe, I.V. Catheter REF 3738222
FDA Enforcement
Class II
·Ongoing·Delta Med SpA·August 25, 2021
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
FDA Enforcement
Class II
·Ongoing·Delta Med SpA·August 25, 2021
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
FDA Enforcement
Class II
·Ongoing·Delta Med SpA·August 25, 2021
NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
FDA Enforcement
Class II
·Ongoing·Delta Med SpA·August 25, 2021
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
FDA Enforcement
Class II
·Ongoing·Delta Med SpA·August 25, 2021
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 16, 2022
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
FDA Enforcement
Class II
·Ongoing·New Medical Technologies Gmbh·February 12, 2025
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
FDA Enforcement
Class II
·Ongoing·New Medical Technologies Gmbh·February 12, 2025
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·September 7, 2022
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·June 29, 2022
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·June 21, 2023
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
FDA Enforcement
Class II
·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 22, 2025
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
FDA Enforcement
Class II
·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 2, 2024