Data / Medical devices / Netherlands / BRDH
BRDH: FDA-registered device maker in Roden Drenthe, Netherlands, 71 510(k) clearances and 1 PMA approval
BRDH is registered with the FDA (registration 3017196117) in Roden Drenthe, Netherlands. It lists 35 device types. The FDA files 71 510(k) clearances and 1 PMA approval under its listings, the newest dated April 10, 2026. Registered through 2026. 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.
- FDA registration number
- 3017196117
- Address
- Burgemeester van Wageningenlaan 35, Roden Drenthe, Netherlands, 9301 BS
- Owner or operator
- BRDH (10076038)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 6, 2020
- Registered through
- 2026
- Brand names listed
- 00-8800-000-10, 1665G, 173022, 174006, 176630, 176647, 212034, 212133 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2026 | K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads | GDW | Substantially Equivalent | Covidien (Part of Medtronic) | accessdata.fda.gov |
| August 16, 2023 | K231491 | TA Stapler and Loading Unit with DST Series Technology | GAG | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 5, 2022 | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 30, 2022 | K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 29, 2022 | K221005 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 25, 2021 | K212146 | Arthrex LoopLoc Knotless Suture | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 1, 2021 | K203393 | FAST-FIX FLEX | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 15, 2020 | K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| September 3, 2020 | K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 21, 2020 | K201749 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 29, 2020 | K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| March 13, 2020 | K192720 | GIA Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 28, 2020 | K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| August 6, 2018 | K173845 | Arthrex SwiveLock | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 23, 2018 | K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| February 16, 2018 | K172361 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 4, 2017 | K172092 | Reprocessed Shavers/Burs | HRX | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| April 21, 2017 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 9, 2016 | K161581 | Arthrex Synergy RF System | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 26, 2016 | K160176 | Signia Stapler | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 24, 2016 | K151342 | Arthrex SwiveLock Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 20, 2015 | K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 2, 2015 | K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 18, 2015 | K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| January 27, 2015 | K142929 | Ligasure Blunt Tip Sealer/Divider | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 5, 2013 | K132079 | TFCC FAST-FIX KIT | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 3, 2013 | K133314 | HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 17, 2013 | K132612 | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| August 22, 2013 | K131969 | SYMBOTEX(TM) COMPOSITE MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 18, 2012 | K121861 | SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 3, 2012 | K121194 | ENDO CLIP III 5MM CLIP APPLIER | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 19, 2011 | K112990 | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 25, 2011 | K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| September 1, 2011 | K112349 | VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| March 25, 2011 | K110699 | LIGAMAX 5 | FZP | Substantially Equivalent | Ethicon Endo-Sugery, LLC | accessdata.fda.gov |
| October 22, 2010 | K101679 | ARTHREX PUSHLOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 17, 2010 | K100242 | AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER | FZP | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| January 28, 2010 | K092508 | FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 14, 2009 | K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | OCW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 23, 2009 | K082810 | ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 23, 2008 | K083638 | FIXATION TROCARS | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| October 5, 2007 | K072674 | KII TROCAR SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| July 3, 2007 | K071622 | ARTHREX FIBERWIRE | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 29, 2007 | K071257 | MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD | JDR | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| October 23, 2006 | K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | GDW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| October 19, 2006 | K061863 | ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 25, 2006 | K061665 | ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 7, 2006 | K060629 | GELPORT BLUNT TIP TROCAR SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| December 13, 2005 | K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 5, 2005 | K051989 | GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE | JDR | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| April 15, 2005 | K050358 | ARTHERX CORKSCREW FT II SUTURE ANCHOR | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 16, 2005 | K043248 | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 4, 2004 | K041356 | ARTHREX TENODESIS SCREW FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 14, 2004 | K041795 | MODIFICATION TO OPTICAL SEPARATOR SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| August 5, 2004 | K041589 | ARTHREX FIBERWIRE WITH SILK | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 14, 2004 | K032245 | ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 | GAT | Unknown | Arthrex, Inc. | accessdata.fda.gov |
| May 29, 2003 | K031011 | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| November 7, 2002 | K021434 | ARTHREX FIBERWIRE IN USP SIZES | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 2, 2002 | K020043 | 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 26, 2001 | K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| June 22, 1999 | K984240 | ENDOPATH ENDOSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| August 6, 1998 | K974847 | 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 20, 1995 | K954853 | AUTO SUTURE SUTURE CLOSURE | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 14, 1994 | K941285 | ARTHREX GRAFT HARVESTING KIT | KIJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 26, 1994 | K935426 | PREPERITONEAL DISTENTION BALLOON SYSTEM | GCJ | Substantially Equivalent | Origin Medsystems, Inc. | accessdata.fda.gov |
| September 17, 1992 | K920068 | AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| November 5, 1986 | K864102 | LIGACLIP 20/20* MULTIPLE CLIP APPLIER | FZP | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 28, 1977 | K771412 | LIGACLIP MULTIPLE CLIP APPLIER | GDO | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 28, 2001 | P010013 | NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM | MNB | 86 | December 17, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Clip, Implantable
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Screw, Fixation, Bone
- All makers of Washer, Bolt Nut
Updated April 10, 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.