Data / Medical devices / Filler, Bone Void, Calcium Compound
Filler, Bone Void, Calcium Compound (MQV): 145 FDA-registered makers in 15 countries
145 establishments in 15 countries are registered with the FDA to make Filler, Bone Void, Calcium Compound (product code MQV, Class 2, 21 CFR 888.3045). 93 of them have a 510(k) clearance or PMA approval on file and 17 have a recall event. The FDA has issued 493 510(k) clearances under this code, the latest on September 11, 2026, and lists 46 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- MQV
- Device class
- 2
- Regulation
- 888.3045
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 94 |
| Germany | 9 |
| Taiwan | 6 |
| United Kingdom | 5 |
| Switzerland | 5 |
| France | 5 |
| Japan | 4 |
| Finland | 4 |
| Netherlands | 3 |
| Malaysia | 3 |
| Sweden | 2 |
| Ireland | 2 |
| South Korea | 1 |
| China | 1 |
| Poland | 1 |
Makers of Filler, Bone Void, Calcium Compound
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 25 | September 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer, Repackager or relabeler | 24 | September 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Isotis Orthobiologics, Inc | Irvine, CA, United States | Complaint file establishment, Manufacturer | 16 | September 25, 2024 | 0 | 3 | 0 | api.fda.gov |
| Depuy Spine, Inc. | Raynham, MA, United States | Complaint file establishment, Specification developer | 12 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Apatech Ltd. | ELSTREE Hertfordshire, United Kingdom | Manufacturer, Specification developer | 11 | August 2, 2024 | 0 | 1 | 0 | api.fda.gov |
| Kuros Biosciences BV | Bilthoven Utrecht, Netherlands | Complaint file establishment, Manufacturer | 11 | May 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Novabone Products, LLC | Alachua, FL, United States | Manufacturer | 11 | March 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 10 | August 14, 2015 | 0 | 1 | 0 | api.fda.gov |
| Berkeley Advanced Biomaterials | Berkeley, CA, United States | Manufacturer | 9 | October 30, 2017 | 0 | 1 | 0 | api.fda.gov |
| Collagen Matrix, Inc. | Mahwah, NJ, United States | Contract manufacturer, Repackager or relabeler | 8 | March 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Manufacturer, Repackager or relabeler | 8 | March 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Specification developer | 8 | February 12, 2016 | 0 | 1 | 0 | api.fda.gov |
| Abyrx, Inc. | Stamford, CT, United States | Complaint file establishment, Manufacturer | 7 | December 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 7 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 7 | August 26, 2014 | 0 | 1 | 0 | api.fda.gov |
| Bioventus LLC | Durham, NC, United States | Repackager or relabeler, Specification developer | 6 | June 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 6 | April 2, 2009 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 6 | January 27, 2011 | 0 | 3 | 0 | api.fda.gov |
| Biocomposites Ltd. | Keele Staffordshire, United Kingdom | Manufacturer | 5 | February 4, 2022 | 0 | 1 | 0 | api.fda.gov |
| Biogennix, LLC | Irvine, CA, United States | Manufacturer | 5 | March 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc. | Oakland, NJ, United States | Contract manufacturer, Specification developer | 5 | March 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc | Allendale, NJ, United States | Contract manufacturer, Manufacturer | 5 | March 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| DSM Biomedical, Inc. | Exton, PA, United States | Contract manufacturer, Manufacturer | 5 | March 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Formosa Biomedical Technology Corporation | Taipei, Taiwan | Manufacturer | 5 | February 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 5 | October 8, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 5 | March 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Surgentec LLC | Boca Raton, FL, United States | Manufacturer | 5 | July 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 5 | January 27, 2011 | 0 | 0 | 0 | api.fda.gov |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Manufacturer, Repackager or relabeler | 5 | August 18, 2015 | 0 | 1 | 0 | api.fda.gov |
| Zavation | Flowood, MS, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 5 | January 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 4 | January 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Arteriocyte Medical Systems, Inc. | Hopkinton, MA, United States | Manufacturer | 4 | September 26, 2011 | 0 | 0 | 0 | api.fda.gov |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | Alachua, FL, United States | Manufacturer | 4 | October 24, 2007 | 0 | 5 | 0 | api.fda.gov |
| Synergy Biomedical | Wayne, PA, United States | Complaint file establishment, Specification developer | 4 | September 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 3 | June 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Curasan AG | KLEINOSTHEIM Bavaria, Germany | Specification developer | 3 | September 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Curasan AG, Frankfurt Facility | FRANKFURT Hesse, Germany | Manufacturer | 3 | September 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Geistlich Pharma AG | WOLHUSEN Luzern, Switzerland | Complaint file establishment, Manufacturer | 3 | June 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hans Biomed Corp. | Daejeon, South Korea | Manufacturer | 3 | February 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Deggendorf GMBH | DEGGENDORF Bavaria, Germany | Manufacturer | 3 | April 19, 2013 | 0 | 0 | 0 | api.fda.gov |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Olyphant, PA, United States | Manufacturer | 3 | September 28, 2009 | 0 | 0 | 0 | api.fda.gov |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Edison, NJ, United States | Manufacturer | 3 | September 28, 2009 | 0 | 4 | 0 | api.fda.gov |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Jessup, PA, United States | Manufacturer | 3 | September 28, 2009 | 0 | 0 | 0 | api.fda.gov |
| Noraker | LYON Auvergne-Rhone-Alpes, France | Manufacturer | 3 | December 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Orthorebirth Co., Ltd. | Yokohama Kanagawa, Japan | Exporter to the US, Specification developer | 3 | March 4, 2024 | 0 | 1 | 0 | api.fda.gov |
| Secada Medical, LLC D.B.A Ventris Medical | Newport Beach, CA, United States | Complaint file establishment, Specification developer | 3 | March 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Acro Biomedical Co., Ltd. | Kaohsiung, Taiwan | Manufacturer | 2 | October 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Agnovos Healthcare Usa, LLC | Rockville, MD, United States | Complaint file establishment, Manufacturer | 2 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Allosource | Centennial, CO, United States | Contract manufacturer, Manufacturer | 2 | January 10, 2011 | 0 | 1 | 0 | api.fda.gov |
| Amend Surgical, Inc. | Alachua, FL, United States | Manufacturer | 2 | February 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Manufacturer | 2 | January 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Bonalive Ltd | Turku Varsinais-Suomi, Finland | Manufacturer | 2 | July 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Biocomposites GmbH (former ARTOSS GmbH) | Rostock Mecklenburg-Western Pomerania, Germany | Manufacturer | 2 | April 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dimensional Bioceramics, LLC | Scotts Valley, CA, United States | Manufacturer, Specification developer | 2 | April 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Elute, Inc. | Salt Lake City, UT, United States | Specification developer | 2 | February 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| ETEX Corporation | Braintree, MA, United States | Specification developer | 2 | June 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 2 | November 27, 2012 | 0 | 1 | 0 | api.fda.gov |
| Inion OY | TAMPERE Pirkanmaa, Finland | Contract manufacturer, Manufacturer | 2 | July 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| LDR Medical | Sainte-Savine Aube, France | Specification developer | 2 | December 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 2 | February 9, 2009 | 0 | 0 | 0 | api.fda.gov |
| Ossdsign | Uppsala, Sweden | Specification developer | 2 | September 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Osteonovus, Inc. | Toledo, OH, United States | Manufacturer | 2 | April 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Osteotech, Inc. | Eatontown, NJ, United States | Manufacturer | 2 | October 16, 2008 | 0 | 0 | 0 | api.fda.gov |
| Science & Bio Materials, S.B.M. SAS | LOURDES Hautes-Pyrenees, France | Complaint file establishment, Manufacturer | 2 | July 3, 2007 | 0 | 1 | 0 | api.fda.gov |
| SYNTHES GMBH / Synthes Produktions GmbH | Oberdorf, Baselland Basel-Landschaft, Switzerland | Manufacturer | 2 | January 7, 2005 | 0 | 0 | 0 | api.fda.gov |
| Teknimed SAS | L Union Haute-Garonne, France | Complaint file establishment, Manufacturer | 2 | May 3, 2004 | 0 | 1 | 0 | api.fda.gov |
| Xenco Medical LLC | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | September 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Acuitive Technologies | Allendale, NJ, United States | Manufacturer | 1 | November 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Anika Therapeutics, Inc. | Bedford, MA, United States | Manufacturer | 1 | December 26, 2017 | 0 | 0 | 0 | api.fda.gov |
| Austin Medical Ventures, Inc. | Germantown, TN, United States | Specification developer | 1 | October 30, 2003 | 0 | 0 | 0 | api.fda.gov |
| Advanced Medical Solutions (Nantes) SAS | VIGNEUX DE BRETAGNE Loire-Atlantique, France | Manufacturer | 1 | January 20, 2006 | 0 | 0 | 0 | api.fda.gov |
| Allgens Medical Technology Co.,Ltd. | Beijing, China | Complaint file establishment, Manufacturer | 1 | July 9, 2015 | 0 | 0 | 0 | api.fda.gov |
| ArthroCare Corporation | Austin, TX, United States | Specification developer | 1 | April 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| Biomendex OY | Tampere Pirkanmaa, Finland | Manufacturer | 1 | February 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Complaint file establishment, Specification developer | 1 | April 2, 2009 | 0 | 0 | 0 | api.fda.gov |
| Biostone Co. Ltd. | Nottingham Nottinghamshire, United Kingdom | Manufacturer | 1 | April 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Bone Solutions, Inc. | Colleyville, TX, United States | Manufacturer | 1 | October 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bone Support AB | LUND Skane, Sweden | Complaint file establishment, Manufacturer | 1 | October 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cytophil, Inc | East Troy, WI, United States | Contract manufacturer, Manufacturer | 1 | December 27, 2010 | 0 | 0 | 0 | api.fda.gov |
| Depuy CMW | Blackpool, Lancashire, United Kingdom | Specification developer | 1 | March 8, 2002 | 0 | 0 | 0 | api.fda.gov |
| Heraeus Medical LLC - Bioresobables | Yardley, PA, United States | Specification developer | 1 | May 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 1 | September 3, 2008 | 0 | 0 | 0 | api.fda.gov |
| Molecular Matrix | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | December 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Oriental Resources Development Limited | Hukou Township Hsinchu(County), Taiwan | Manufacturer | 1 | February 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Manufacturer | 1 | May 21, 2009 | 0 | 1 | 0 | api.fda.gov |
| OSferionBiomaterials Corp. Mishima Factory | Sunto-gun Shizuoka, Japan | Manufacturer | 1 | May 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| Revogen Biologics | San Antonio, TX, United States | Specification developer | 1 | April 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Riverside Medical Packaging Company Ltd | Derby Derbyshire, United Kingdom | Contract manufacturer, Repackager or relabeler | 1 | April 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Signus Medizintechnik GMBH | ALZENAU Bavaria, Germany | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 1 | September 28, 2009 | 0 | 0 | 0 | api.fda.gov |
| SpineSmith Holdings, LLC | Austin, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | May 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | November 26, 2002 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 1 | December 16, 2005 | 0 | 0 | 0 | api.fda.gov |
| Wiltrom Corporation Limited | Zhubei City Hsinchu(County), Taiwan | Complaint file establishment, Manufacturer | 1 | February 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arctic Biomaterials OY | Tampere Pirkanmaa, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptyx - Charlotte | Charlotte, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BBF Sterilisationsservice GMBH | Kernen Baden-Wurttemberg, Germany | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioplate, Inc. | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cam Bioceramics | LEIDEN Zuid-Holland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citra Labs LLC | Braintree, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam West LLC | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Friedrich Daniels GMBH | SOLINGEN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G-5 Florida LLC | Jax, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HCM Medical | Nijmegen Gelderland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Howmedica International S. De R.L. | LIMERICK Munster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Himed, LLC | Old Bethpage, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ipax, Inc. | Englewood, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & J Precision Technologies, LLC | Lititz, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaigen Pharma Co., Ltd. Tenjin Factory | Otaru-shi Hokkaido, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifenet Health | Virginia Beach, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lyophilization Services Of New England, Inc. | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health | Virginia Bch, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health | Plainfield, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health Northwest | Renton, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maxigen Biotech, Inc. | Taoyuan City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MedSkin Solutions Dr. Suwelack AG | BILLERBECK North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Testing - CT, LLC | Willington, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NML Medical, LLC | West Carrollton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nelipak Healthcare Packaging | CLARA, Offaly, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nissha Precision and Technologies, Inc. | Kyoto, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nolato Stargard Sp. z o.o. | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PDV MedTech | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poly-Med, Inc. | Anderson, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Bioresources, Inc | Seguin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roechling Medical Lancaster, LLC | Denver, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syntec Scientific Corp. | CHANG HUA Changhua, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The E F PRECISION GROUP | Willow Grove, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tissue Transplant Technology, Ltd. d/b/a Bone Bank Allografts | San Antonio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WHK Biosystems, LLC | Clearwater, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.