# Biomedical Ent., Inc.

- Location (FDA's records): San Antonio, TX
- FDA decisions: 13 (1996–2014): 13 510(k) clearances
- Product codes: JDR (6), GEY (3), HTY (2), HBW (1), JEY (1)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 41 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomedical Enterprises, Inc.: 2 (https://510kreport.com/company/biomedical-enterprises)
- Memometal Technologies: 2 (https://510kreport.com/company/memometal-technologies)
- Landos, Inc.: 1 (https://510kreport.com/company/landos)
- Hemostatic Surgery Corp.: 1 (https://510kreport.com/company/hemostatic-surgery)

## Firms that cite its devices most
- Biomedical Enterprises, Inc.: 15 (https://510kreport.com/company/biomedical-enterprises)
- Mx Orthopedics, Corp.: 4 (https://510kreport.com/company/mx-orthopedics)
- Dallen Medical, Inc.: 2 (https://510kreport.com/company/dallen-medical)
- Core Essence Orthopaedics, LLC: 2 (https://510kreport.com/company/core-essence-orthopaedics)
- Orthohelix Surgical Designs, Inc.: 2 (https://510kreport.com/company/orthohelix-surgical-designs)
- Vilex IN Tennessee, Inc.: 2 (https://510kreport.com/company/vilex-in-tennessee)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)

## Its most-cited devices
- K993714: Memograph Staple, Warm System (2000), cited by 18
- K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System (2001), cited by 7
- K001353: Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System (2001), cited by 3
- K001219: Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple  System (2000), cited by 3
- K102107: Osstaple Chill (2010), cited by 3
- K091951: Hammerlock (2010), cited by 2

## Recent decisions
- K133844: Speed Triad (Apr 7, 2014)
- K133780: Speed XL (Mar 19, 2014)
- K131640: Smooth or Threaded Metallic Bone Fastener (Oct 16, 2013)
- K102107: Osstaple Chill (Sep 3, 2010)
- K091951: Hammerlock (Feb 19, 2010)
- K023203: Osstaple (Oct 17, 2002)
- K001353: Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System (Mar 13, 2001)
- K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System (Mar 13, 2001)

Source page: https://510kreport.com/company/biomedical-ent