38 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
FDA Enforcement
Class I
·Ongoing·ROi CPS LLC·February 12, 2025
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
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
GE Heathcare Giraffe OmniBed; neo natal incubator
FDA Enforcement
Class I
·Ongoing·DATEX--OHMEDA, INC.·October 23, 2024
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-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
FDA Enforcement
Class I
·Ongoing·Mercury Enterprises, Inc. dba Mercury Medical·October 9, 2024
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 16, 2022
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
FDA Enforcement
Class I
·Ongoing·DATEX--OHMEDA, INC.·October 23, 2024
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
FDA Enforcement
Class I
·Ongoing·SonarMed Inc·April 24, 2024
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
FDA Enforcement
Class I
·Ongoing·SonarMed Inc·April 24, 2024
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
FDA Enforcement
Class I
·Ongoing·SonarMed Inc·April 24, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024