20 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
FDA Enforcement
Class I
·Ongoing·Medical Action Industries, Inc. 306·May 13, 2026
Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acute and chronic renal failure during hemodialysis procedure.
FDA Enforcement
Class I
·Terminated·Fresenius Medical Care Holdings, Inc.·July 4, 2012
Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure.
FDA Enforcement
Class I
·Terminated·Fresenius Medical Care Holdings, Inc.·July 4, 2012
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
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T GEN 2 Bibag without CDX
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T HD SYS. CDX BLUESTAR
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T HD SYS. W/O CDX BLUESTAR
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T Hemodialysis System without CDX
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
stay-safe /Luer Lock Adapter 4 in
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 3, 2024
stay-safe /Luer Lock Catheter Ext. 18 in
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 3, 2024
stay-safe /Safe Lock Catheter Ext. 12 in
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 3, 2024
2008T Hemodialysis System w/Bibag
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T Hemodialysis SYS, with CDX
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
stay-safe /Luer Catheter Ext. 6 in
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 3, 2024
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
stay-safe /Luer Lock Catheter Ext. 12 in
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 3, 2024