FDA.reportPublic FDA data

BioMedical Enterprises, Inc.

Matched from indexed company URL: Biomedical Enterprises, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16492633000718642BioMedical Enterprises, Inc.1N2020-04-2514785 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 GUDIDProductPhoneEmail
00810633020005HammerLock - Medium, 19mm length Nitinol Intramedullary Implant210-881-0043gupton@bme-tx.com
00810633020005HammerLock - Medium, 19mm length Nitinol Intramedullary Implant210-881-0064aknight@bme-tx.com
00810633020012HammerLock - Hammerlock implant for DIP210-881-0064aknight@bme-tx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
523181433275892K191463DePuy Synthes Hammertoe Continuous Compression ImplantJDR2020-02-26
523181825392328K150125Elite Nitinol Fixation SystemJDR2015-05-11
523181276137934K143023Nitinol Compression Plating SystemHRS2015-01-16
523181661430937K142292Speed, Speed Shift, Speed Titan, Speed ArcJDR2014-11-17
523181984034764K133844SPEED TRIADJDR2014-04-07
523181773746374K133780SPEED XLJDR2014-03-19
523181262298124K133520HAMMERLOCK 2HTY2014-01-09
523181412727688K133270SPEED ARCJDR2014-04-17
523181203743011K131640SMOOTH OR THREADED METALLIC BONE FASTENERHTY2013-10-16
523181918669248K124022SPEED SHIFTJDR2013-05-14
523181619451403

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JDR72020-02-26
HTY22014-01-09
HRS12015-01-16

PMN#

Converge

2016-08-11

BIOMEDICAL ENTERPRISES, INC

SPEED ARC

2014-04-17

BIOMEDICAL ENTERPRISES, INC

GUDID#

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