BioMedical Enterprises, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1649263	3000718642	BioMedical Enterprises, Inc.	1	N	2020-04-25	14785 OMICRON DR., SUITE 205 SAN ANTONIO TX US 78245

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00810633020005	HammerLock - Medium, 19mm length Nitinol Intramedullary Implant	210-881-0043	gupton@bme-tx.com
00810633020005	HammerLock - Medium, 19mm length Nitinol Intramedullary Implant	210-881-0064	aknight@bme-tx.com
00810633020012	HammerLock - Hammerlock implant for DIP	210-881-0064	aknight@bme-tx.com

bme-tx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
52318	1433275892	K191463	DePuy Synthes Hammertoe Continuous Compression Implant	JDR	2020-02-26
52318	1825392328	K150125	Elite Nitinol Fixation System	JDR	2015-05-11
52318	1276137934	K143023	Nitinol Compression Plating System	HRS	2015-01-16
52318	1661430937	K142292	Speed, Speed Shift, Speed Titan, Speed Arc	JDR	2014-11-17
52318	1984034764	K133844	SPEED TRIAD	JDR	2014-04-07
52318	1773746374	K133780	SPEED XL	JDR	2014-03-19
52318	1262298124	K133520	HAMMERLOCK 2	HTY	2014-01-09
52318	1412727688	K133270	SPEED ARC	JDR	2014-04-17
52318	1203743011	K131640	SMOOTH OR THREADED METALLIC BONE FASTENER	HTY	2013-10-16
52318	1918669248	K124022	SPEED SHIFT	JDR	2013-05-14
52318	1619451403

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JDR	7	2020-02-26
HTY	2	2014-01-09
HRS	1	2015-01-16

PMN#

Elite Nitinol Fixation System
2015-05-11
BioMedical Enterprises, Inc.
Nitinol Compression Plating System
2015-01-16
BioMedical Enterprises, Inc.
Speed, Speed Shift, Speed Titan, Speed Arc
2014-11-17
BioMedical Enterprises, Inc.

GUDID#

HammerLock - Medium, 19mm length Nitinol Intramedullary Implant
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock implant for DIP
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock X-Type Large
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock Angled X-Type Large
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock Angled X-Type Medium 19
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock X-Type Petite
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock X-Type Small
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock Angled X-Type Small 16mm
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Medium, 19mm length Nitinol Intramedullary Implant
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock implant for DIP
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock X-Type Large
Biomedical Enterprises, Inc.
2015-10-24
HammerLock - Hammerlock Angled X-Type Large
Biomedical Enterprises, Inc.
2015-10-24
Speed - SPEED 15X15X15mm implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - SPEED 18X15X15mm implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - SPEED 18X18X18mm implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - SPEED 18X18X15mm implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - SPEED 20X15X15mm implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - SPEED 20X20X20mm implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - SPEED 25X20X20mm implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - Lite SPEED 09X07X07mm nitinol implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - Lite SPEED 09X10X10mm nitinol implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - Lite SPEED 11X10X10mm nitinol implant
Biomedical Enterprises, Inc.
2015-10-24
Speed - Lite SPEED 11X15X13mm nitinol implant
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 07X05W1.5
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - Step OSStaple 20X20X20 W2X3
Biomedical Enterprises, Inc.
2015-10-24
Speed Shift - Speed Shift 20x20x20 Offset 02mm Implant
Biomedical Enterprises, Inc.
2015-10-24
Speed Shift - Speed Shift 20x20x20 Offset 04mm Implant
Biomedical Enterprises, Inc.
2015-10-24
Speed Shift - Speed Shift 20x20x20 Offset 12mm Implant
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 07X05W1.2
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 09X07W1.5
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 11X10W1.5
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 15X12W2
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 20X20 W2X3
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 15X15W2
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 09X07W1.2
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 18X25W2
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 18X18X15W2
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 20X20W2
Biomedical Enterprises, Inc.
2015-10-24
OSStaple - OSStaple 18X30W2X3
Biomedical Enterprises, Inc.
2015-10-24
Step Boss - Step Boss 20X20X20X12W2X3
Biomedical Enterprises, Inc.
2015-10-24

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