Company ยท US
Excelsior Medical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2014. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 2014 | K142620 | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, Excelsior Medical Corporation | NGT |
| Nov 14, 2014 | K133446 | HEPARIN LOCK / FLUSH SYRINGES Excelsior Medical Corporation | NZW |
| Dec 24, 2013 | K130975 | SWABCAP AND SWABFLUSH Excelsior Medical Corp. | QBP |
| Feb 10, 2011 | K101270 | SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 Excelsior Medical Corp., CA | NGT |
| Apr 28, 2009 | K083508 | SWABCAP Excelsior Medical Corp., CA | QBP |
| Dec 18, 2008 | K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) Excelsior Medical Corp. | NGT |
| Feb 23, 2007 | K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML Excelsior Medical Corp. | NZW |
| Dec 9, 2005 | K053120 | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES Excelsior Medical Corp. | FOZ |
| May 13, 2003 | K023740 | SYREX PRE-FILLED SYRINGE Excelsior Medical Corp. | NZW |
| Oct 25, 1996 | K962938 | EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) Excelsior Medical Corp. | FOZ |
| Feb 8, 1995 | K942349 | MICROBORE EXTENSION SET Excelsior Medical Corp. | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2016 | Excelsior Medical Corp Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only. Terminated |
NZW | K023740 |
| Jul 16, 2014 | Excelsior Medical Corp Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer Terminated |
LHI | K913804 |
| Jun 5, 2012 | Excelsior Medical Corp Heparin Lock Flush Solution 100 Unit/mL, USP
3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR
Excelsior Medical Neptune, NJ 07753
(800) 487-4276
Made in USA
NDC 63807060055.
Used to maintain Terminated |
NZW | K061497 |
| Oct 20, 2010 | Excelsior Medical Corp Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride)
General hospital use Terminated |
NGT | K090882 K962938 |
| Feb 6, 2009 | Excelsior Medical Corp Sterile Field Saline Flush;
0.9% Sodium Chloride Injection, USP; Rx Only; Single Use.
Excelsior Medical, Neptune, NJ.
This product is used for the flushing of venous access devices and intravenous tu Terminated |
NGT | K053120 |
| Oct 19, 2006 | Excelsior Medical Corp 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex. Terminated |
NGT | None listed |
| May 17, 2006 | Excelsior Medical Corp ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ. Terminated |
FRN | K914988 |