46 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·July 25, 2012
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
FDA Enforcement
Class II
·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·July 11, 2012
Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
FDA Enforcement
Class II
·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·July 11, 2012
Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
FDA Enforcement
Class II
·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·July 11, 2012
Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
FDA Enforcement
Class II
·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·July 11, 2012
Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·December 11, 2013
Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·December 11, 2013
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·December 11, 2013
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