ClearanceBrief
Company · US

Mozarc Medical US LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2026 to 2026. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (1 in 12 months)
12recalls (1 in 12 months)
12recalls that name a 510(k)

Product codes

CodeDeviceRecords
NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted6
MSDCatheter, Hemodialysis, Implanted5
FIENeedle, Fistula1
MPBCatheter, Hemodialysis, Non-Implanted1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 6, 2026K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Refl
Mozarc Medical Us, LLC
FIE

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 5, 2026Mozarc Medical US LLC
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved
Open, Classified		 MPBK120674
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Open, Classified		 NIEK192302
May 30, 2025Mozarc Medical US LLC
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
May 30, 2025Mozarc Medical US LLC
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
May 30, 2025Mozarc Medical US LLC
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
May 30, 2025Mozarc Medical US LLC
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
May 30, 2025Mozarc Medical US LLC
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
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