8 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Model Number DYNJ42902B; e) CENTRAL LINE PACK - COMPANION, Model Number DYNJ47215D; f) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717A; g) PK CUST CENTRAL LINE PACK, Model Number DYNJ60586; h) TUNNEL LINE PACK, Model Number DYNJ67990; i) CLOSURE PACK, Model Number DYNJ83054A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
ClubMax Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Atom Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Maxim Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Spectrum Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Burstberry Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Logolas Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024