24 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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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
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
FDA Enforcement
Class II
·Ongoing·GRAMERCY EXTREMITY ORTHOPEDICS·April 26, 2023
GEO-MED CATARACT PACK, REF 89-5790.08
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED BIOPSY TRAY, REF 89-8753.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
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