Is this your brand? Sign in to claim ownership.

NIPRO MEDICAL CORPORATION

Last updated September 17, 2026

Information

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

Catalogue (464)

Page 7 of 10

Device	Model / Reference	Registries	Class	Status
Nipro Syringe	JD+03S	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+35180AS	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+43080	FDA UDI	Class II	Unknown
Nipro Syringe	JD+03S2125	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+152530BCR	FDA UDI	Class II	Active
Nipro Syringe	JD+01T-NIJ	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+2425	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+74080	FDA UDI	Class II	Unknown
Nipro Safelet Cath	CI+2050	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+10L2025	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+142530TP	FDA UDI	Class II	Active
Nipro Insulin Syringe	JD+01U3108-SB	FDA UDI	Class II	Active
Nipro Syringe	JD+05L2025	FDA UDI	Class II	Active
NIPRO SafeTouch™ Safety Scalp Vein Set	SPR+21G19	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+44045	FDA UDI	Class II	Unknown
Nipro Syringe	JD+03L2038	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+63045	FDA UDI	Class II	Unknown
Nipro Set Blood Tubing Set	BL+A430/V912-NIJ	FDA UDI	Class II	Active
NIPRO Cellentia™-H Hemodialyzer	Cellentia™-19H	FDA UDI	Class II	Active
Nipro Biohole Needle With Capick Scab Remover	16GX1" HTC-30W-D-CAP	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+30ES-WEI	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2525-NIJ	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2732	FDA UDI	Class II	Active
Nipro Biohole Needle With Capick Scab Remover	16GX1" HC-40W-D-CAP	FDA UDI	Class II	Active
Cronus HP PTA Balloon Catheter	NHP+88080	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+54080	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+01T2713-WEI	FDA UDI	Class II	Active
Nipro Scalp Vein Set	PR+18G19	FDA UDI	Class II	Active
Nipro Syringe	JD+10L2238	FDA UDI	Class II	Active
Nipro Tp-Sure	TPSURE+1	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+153230BC	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+03L-WEI	FDA UDI	Class II	Active
Nipro Twist Lancet	DK-LANCET30100	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2325	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+93045	FDA UDI	Class II	Unknown
NIPRO AQUALiner™	ALS+35260SS	FDA UDI	Class II	Active
Nipro Scalp Vein Set	PR+22G19	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2516	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2338-NIJ	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+53045	FDA UDI	Class II	Unknown
Nipro Safelet Cath	CI+2232	FDA UDI	Class II	Active
Nipro Syringe	JD+05L2138	FDA UDI	Class II	Active
Nipro Solution Infusion Set	IS-01-A/A-21G	FDA UDI	Class II	Active
Cronus HP PTA Balloon Catheter	NHP+76080	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2538-NIJ	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	BL+A209Y/V803-NIJ	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+52080	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+63080	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2325-NIJ	FDA UDI	Class II	Active
Nipro Syringe	JD+01T2609	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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