7 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
AUTO REF/KERATOMETER ARK-1s
FDA Enforcement
Class II
·Terminated·Nidek Inc.·April 18, 2018
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
FDA Enforcement
Class II
·Ongoing·Contamac Solutions, Inc.·June 18, 2025
Widefield OCT software feature for the Spectralis HRA+OCT and variants
FDA Enforcement
Class II
·Terminated·Heidelberg Engineering·May 2, 2018
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FDA Enforcement
Class II
·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FDA Enforcement
Class II
·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026
AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
FDA Enforcement
Class II
·Terminated·Summit Medical, Inc.·December 23, 2015