9 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·May 28, 2014
Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SHUNT PACK, REF PHS392834010D; 7) VP SHUNT, REF SYNJ10307A.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 8, 2025
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·November 6, 2024
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·April 26, 2023
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·July 12, 2023
BostonSight PROSE Lens.
FDA Enforcement
Class II
·Ongoing·Boston Foundation For Sight·August 6, 2025
BostonSight SCLERAL Lens
FDA Enforcement
Class II
·Ongoing·Boston Foundation For Sight·August 6, 2025
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Enforcement
Class II
·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
FDA Enforcement
Class II
·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023