Orbusneich Medical, Inc.

Miramar, FL, US

ORBUSNEICH MEDICAL, INC. appears in FDA device records in Miramar, FL. FDA records list 12 510(k) clearances between 2001-07-31 and 2017-01-05, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 12
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Orbusneich Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Orbus Medical Technologies510(k), recall

510(k) clearance history

FDA records hold 12 510(k) clearances for Orbusneich Medical, Inc. between 2001 and 2017. The busiest year on record is 2003, with 4. The most recent is 2017, with 1.

Clearances by year, as a table

510(k) clearance decisions for Orbusneich Medical, Inc., by decision year
Year	Clearances
2001	1
2003	4
2004	3
2011	2
2016	1
2017	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K163114	Sapphire II PRO	LOX	Substantially Equivalent	2017-01-05
K162209	Sapphire NC Plus	LOX	Substantially Equivalent	2016-10-06
K103808	SAPPHIRE NC	LOX	Substantially Equivalent	2011-09-01
K103657	SAPPHIRE	LOX	Substantially Equivalent	2011-08-09
K041370	LIFESTENT LP SDS BILIARY ENDOPROSTHESIS	FGE	Unknown	2004-06-24
K041032	MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS	FGE	Unknown	2004-05-10
K040550	LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS	FGE	Unknown	2004-03-16
K033212	LIFESTENT SDS BILIARY ENDOPROSTHESIS	FGE	Unknown	2003-10-30
K023308	LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS	FGE	Unknown	2003-04-14
K023121	LIFESTENT BILIARY ENDOPROSTHESIS	FGE	Unknown	2003-03-10
K023248	LIFESTENT LP SDS BILIARY ENDOPROSTHESIS	FGE	Unknown	2003-02-11
K010107	R STENT BILIARY ENDOPROSTHESIS	FGE	Unknown	2001-07-31

Registered establishments

FDA registered establishments for Orbusneich Medical, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1064498	3014148220	ORBUSNEICH MEDICAL, INC.	3350 SW 148th Ave, Suite 110, Miramar, FL 33027, US, Miramar, FL 33027 US	2026	No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1075-04	The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. Ref. Baloon-Expandable Stent and delivery System. Catalog Numbers SD186U14D SD186U24D SD366U14D SD366U24D	BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.		2004-03-19	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain