Nipro Medical Corporation
Nipro Medical Corporation holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 11 FDA device recalls on record.
Top product codes for Nipro Medical Corporation
FDA recalls by Nipro Medical Corporation
10 most recent of 11- Z-0912-2026 — Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
- Z-1876-2018 — Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
- Z-0161-2016 — Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
- Z-0624-2016 — NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.
- Z-0599-2016 — NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.
- Z-1834-2014 — NIPRO Safe Touch Safety Scalp Vein Set
- Z-0137-2013 — AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
- Z-0135-2013 — AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
- Z-0138-2013 — AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
- Z-0136-2013 — AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nipro Medical Corporation
- K261399 — ELISIO-HX
- K253047 — PRESSONE
- K260533 — ELISIO-H
- K222852 — Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
- K212677 — aboNT SYRINGE
- K190037 — Cronus HP PTA Balloon Catheter
- K191359 — Nipro Syringe
- K182940 — Surdial DX Hemodialysis System
- K173029 — Nipro Syringe
- K161681 — Nipro SafeTouch IV Catheter
- K160444 — FB-U Hemodialyzer
- K151141 — Cronus HP - High Pressure Peripheral Balloon Catheter
- K140191 — ELISIO-H HEMODIALYZER
- K140136 — NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
- K131935 — ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
- K131381 — ELISIO-H HEMODIALYZER
- K132153 — SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
- K122952 — NIPRO PUREFLUX-L HEMODIALYZER
- K131641 — MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
- K122343 — PUREFLUX-H HEMODIALYZER
- K122347 — ELISIO-H AND ELISIO-M HEMODIALYZERS
- K130049 — MONOJECT 12ML SYRINGE
- K120490 — QUICK SAMPLER HOLDER
- K113469 — NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
- K113471 — NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
- K113470 — NIPRO SAFE TOUCH HUBER INFUSION SET
- K112628 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
- K113429 — SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
- K100520 — NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
- K092246 — NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
- K091279 — NIPRO DISPOSABLE SYRINGE
- K072988 — NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
- K071145 — NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
- K060034 — NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
- K051828 — NIPRO SUREFUSER AMBULATORY INFUSION PUMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.