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NIPRO MEDICAL CORPORATION

Last updated September 17, 2026

Information

Country: US
Address: 3150 NW 107TH AVE, Doral, FL, 33172
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000132332
DUNS Number: —

Catalogue (464)

Page 9 of 10

Device	Model / Reference	Registries	Class	Status
Nipro Nitrile Powder Free Examination Gloves	GU-NITRILESM-PF-US	FDA UDI	Class I	Active
Nipro Elisio™ -m Hemodialyzer	ELISIO™-13M	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+96045	FDA UDI	Class II	Unknown
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+44080	FDA UDI	Class II	Unknown
NIPRO AQUALiner™	ALS+35260AR	FDA UDI	Class II	Active
Nipro Blood Tubing Set For Hemodialysis With Transducer Protectors And Priming Set	K010264	FDA 510(k)	Class II	Active
Nipro Biohole Needle With Capick Scab Remover	K100520	FDA 510(k)	Class II	Active
Elisio-H Hemodialyzer	K131381	FDA 510(k)	Class II	Active
Nipro Bio-Flex Catheter	K022756	FDA 510(k)	Class II	Active
Nipro Hypodermic Needle	K052474	FDA 510(k)	Class II	Active
Nipro Safetouch Safety Fistula Needle	K002813	FDA 510(k)	Class II	Active
Sniper, Model Or-3872xx Series	K001251	FDA 510(k)	Class II	Active
Elisio-H Hemodialyzer	K140191	FDA 510(k)	Class II	Active
Modification To: Nipro Safe Touch Safety Fistula Needle	K032777	FDA 510(k)	Class II	Active
Nipro Insulin Syringe	K000144	FDA 510(k)	Class II	Active
Nipro Pureflux-L Hemodialyzer	K122952	FDA 510(k)	Class II	Active
Nipro Safetouch Ii Gamma	K063721	FDA 510(k)	Class II	Active
Nipro Disposable Syringe	K091279	FDA 510(k)	Class II	Active
Nipro Safetouch Tulip Safety Fistula Needle	K071145	FDA 510(k)	Class II	Active
Nipro Disposable Stopcocks, Models 3w-Rc. Ncn-3, 3w-R, 3w-L	K041779	FDA 510(k)	Class II	Active
Cronus HP PTA Balloon Catheter	K190037	FDA 510(k)FDA UDI	Class II	Active
Nipro Needleless Transfer Device, Models: M285503 And M285505	K092246	FDA 510(k)	Class II	Active
Nipro Transducer Protector Tp-Sure, Model Tpsure+1	K072988	FDA 510(k)	Class II	Active
Nipro Coreless Needle/Coreless Needle Set	K971582	FDA 510(k)	Class II	Active
aboNT SYRINGE	K212677	FDA 510(k)	Class II	Active
Nipro Huber Infusion, Excel Huber Needle	K113469	FDA 510(k)	Class II	Active
Nipro Safetouch Huber Infustion Set	K081210	FDA 510(k)	Class II	Active
Nipro Biohole Needle	K063368	FDA 510(k)	Class II	Active
Nipro Safetouch Psv Scalp Vein Set With Safety Device	K140136	FDA 510(k)	Class II	Active
Nipro Huber Infusion Set, Excel Huber Infusion Set	K113471	FDA 510(k)	Class II	Active
Monoject 60ml Syringe (luer Lock Tip, Luer Slip Tip, Catheter Tip)	K131641	FDA 510(k)	Class II	Active
Safetouch Psv Winged Infusion Set, And Set With Filter	K113429	FDA 510(k)	Class II	Active
Nipro Blood Collection Needle	K992699	FDA 510(k)	Class II	Active
Nipro Luer Adaptor	K992729	FDA 510(k)	Class II	Active
Appalead Gw+03xxxxxxr Series	K003394	FDA 510(k)	Class II	Active
Pressone™	K253047	FDA 510(k)	Class II	Active
Nipro Safelet Cath	K013287	FDA 510(k)	Class II	Active
Nipro Disposable Syringes	K030683	FDA 510(k)	Class II	Active
Monoject 12ml Syringe	K130049	FDA 510(k)	Class II	Active
Quick Sampler Holder	K120490	FDA 510(k)	Class II	Active
Nipro Safetouch Scalp Vein And Blood Collection Set	K011297	FDA 510(k)	Class II	Active
Nipro Disposable Solution Infusion Set	K972493	FDA 510(k)	Class II	Active
Nipro Arterial Venous Fistula Needle, Agulha Para Fistula Arterio-Venosa, Aguja Para Fistula Arterio Venosa	K991623	FDA 510(k)	Class II	Active
Nipro Blood Tubing Set With Transducer Protector And Priming Set, Model A201-A219, V801-V806, 5m9634, 5m9693	K072024	FDA 510(k)	Class II	Active
Elisio-H Hemodialyzer, Elisio-M Hemodialyzer	K131935	FDA 510(k)	Class II	Active
Pureflux-H Hemodialyzer	K122343	FDA 510(k)	Class II	Active
Nipro Hydrophilic Guidewire For Urological & Laparoscopic Use	K060034	FDA 510(k)	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	K151141	FDA 510(k)	Class II	Active
Nipro Surefuser Ambulatory Infusion Pump	K051828	FDA 510(k)	Class II	Active
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle	K222852	FDA 510(k)	Class II	Active

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 27, 2025	Z-0912-2026	—	open, classified	Screw may loosen or fallout of Hemodialysis system
Dec 19, 2017	Z-1876-2018	—	terminated	There is a possibility of the heparin line is occluded.
Aug 13, 2015	Z-0161-2016	—	terminated	Some 1 1/4" needles were packaged and labeled in the 1" blister package.
Mar 30, 2015	Z-0624-2016	—	terminated	Blood foaming was found during evaluation of the product.
Apr 1, 2014	Z-0599-2016	—	terminated	Device has the potential to have torn wings.
May 4, 2013	Z-1834-2014	—	terminated	There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.
Jul 27, 2012	Z-0135-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0134-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0136-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0137-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0138-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jan 13, 2010	Z-1103-2010	—	terminated	Nipro Medical Corporation, Miami FL is initiating a nationwide recall of all GlucoPro Insulin syringes (This does not include the GlucoPro syringe specific for use with the amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in