Data / Medical devices / Dominican Republic / Covidien
Covidien: FDA-registered device maker in - Santo Domingo, Dominican Republic, 79 510(k) clearances
Covidien is registered with the FDA (registration 9612501) in - Santo Domingo, Dominican Republic. It lists 66 device types. The FDA files 79 510(k) clearances under its listings, the newest dated May 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612501
- FEI number
- 3003495548
- Address
- ZONA FRANCA DE SAN ISIDRO Carretera San Isidro, Km 17, - Santo Domingo, Dominican Republic, -
- Owner or operator
- Covidien llc (1282497)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 11, 1994
- Registered through
- 2026
- Brand names listed
- ALAR Nasal Valve Stent, AccuGuide Injection Monitor, Needle Electrode, Activent Ventilation Tube, Appose Skin Staplers, ArthroPort, Austin Modified Total Ossicular Replacement, Austin Modified Ttotal Ossicular replacement, BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM 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 |
|---|---|---|---|---|---|---|
| May 28, 2026 | K253530 | Trexon Monofilament Synthetic Absorbable Suture | GAM | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| December 3, 2025 | K250725 | Hugo RAS System | SCV | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 3, 2024 | K241486 | Sofsilk Coated Braided Silk Suture | GAP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 27, 2022 | K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 8, 2017 | K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar | GCJ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| October 18, 2016 | K162584 | VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 1, 2016 | K160230 | VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 22, 2016 | K152149 | VersaOne Bladed Trocar 5mm | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 29, 2015 | K151758 | ALAR Nasal Valve Stent | GAT | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| September 14, 2015 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 2, 2015 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 29, 2015 | K142656 | Surgical Gut Suture | GAL | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 9, 2014 | K142547 | Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 14, 2013 | K130435 | VERSAPORT V2 BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| May 3, 2012 | K121194 | ENDO CLIP III 5MM CLIP APPLIER | FZP | Substantially Equivalent | Covidien | 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 |
| April 26, 2010 | K100548 | VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS Tyco Healthcar | 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 |
| December 9, 2009 | K093750 | ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA | KRA | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| May 23, 2008 | K081169 | AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS United States | accessdata.fda.gov |
| November 21, 2007 | K071406 | AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER | FZP | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| October 5, 2006 | K062779 | DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) | GCJ | Substantially Equivalent | New Wave Surgical Corporation | accessdata.fda.gov |
| September 1, 2006 | K062326 | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| January 4, 2006 | K051990 | ECHELON MICRO CATHETER | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| June 1, 2005 | K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | GAW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| September 2, 2004 | K042187 | ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| November 17, 2003 | K032586 | CAPROSYN ABSORBABLE SUTURE | GAM | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| August 7, 2003 | K031992 | ECHELON MICRO CATHETER, MODEL 105-5091 | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| March 28, 2003 | K030688 | ECHELON MICRO CATHETER, MODEL 105-5092-150 | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| July 15, 2002 | K012543 | VISION SCIENCES ENDOSHEATH SYSTEM | EOB | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| September 6, 2001 | K012539 | VERASTEP | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| April 9, 2001 | K010909 | NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE | GAW | Substantially Equivalent | Tyco Healthcare Group LP | accessdata.fda.gov |
| September 28, 2000 | K002723 | REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| July 20, 2000 | K001966 | REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| March 30, 2000 | K000037 | MONOFILAMENT BIOSYN SUTURE | GAM | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| January 4, 2000 | K993672 | REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| July 30, 1999 | K992288 | AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE | GCJ | Substantially Equivalent | Tyco Intl. (Us), Inc. | accessdata.fda.gov |
| April 1, 1999 | K990952 | NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES | GAT | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| April 1, 1999 | K990951 | MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE | GAM | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| July 29, 1998 | K981941 | MULTAPORT CANNULA REDUCER AND ACCESSORIES | GCJ | Substantially Equivalent | Dexide, Inc. | accessdata.fda.gov |
| July 13, 1998 | K981582 | SURGILON, DERMALON, & OPHTHALON | GAR | Substantially Equivalent | Davis & Geck, Inc. | accessdata.fda.gov |
| June 25, 1998 | K981935 | POLYSORB SUTURE | GAM | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| May 11, 1998 | K981128 | SOFSILK SUTURE | GAP | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| January 16, 1998 | K973046 | SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK | GCJ | Substantially Equivalent | General Surgical Innovations | accessdata.fda.gov |
| February 12, 1997 | K963115 | TROCAR CANNULA | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| October 8, 1996 | K963253 | SYNTHETIC ABSORBABLE SURGICAL SUTURE | GAM | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| July 10, 1996 | K961940 | INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP | GCJ | Substantially Equivalent | Innerdyne, Inc. | accessdata.fda.gov |
| May 28, 1996 | K961430 | INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP | GCJ | Substantially Equivalent | Innerdyne, Inc. | accessdata.fda.gov |
| February 27, 1996 | K955747 | USSC NONABSORBABLE SUTURES | GAT | Substantially Equivalent for Some Indications | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| February 27, 1996 | K955723 | STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) | GAQ | Substantially Equivalent for Some Indications | Davis & Geck, Inc. | accessdata.fda.gov |
| February 27, 1996 | K954808 | USSC POLYPROPLENE SUTURE | GAW | Substantially Equivalent for Some Indications | United States Surgical, A Division of Tyco Healthc | 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 |
| October 23, 1995 | K954435 | WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES | FZP | Substantially Equivalent | Wilo Medizintechnik Lothar Wilberg GmbH | accessdata.fda.gov |
| October 17, 1995 | K954108 | MODIFIED VERSAPORT | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| August 21, 1995 | K953289 | TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET | DXZ | Substantially Equivalent | Davis & Geck, Inc. | accessdata.fda.gov |
| July 17, 1995 | K952977 | SABRE MULTI-USE TROCAR SYSTEM | GCJ | Substantially Equivalent | Endoscopic Concepts, Inc. | accessdata.fda.gov |
| May 12, 1995 | K950632 | INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP | GCJ | Substantially Equivalent | Innerdyne, Inc. | accessdata.fda.gov |
| January 24, 1995 | K945701 | SURGILENE(R) SUTURES | GAW | Substantially Equivalent for Some Indications | Davis & Geck, Inc. | accessdata.fda.gov |
| November 21, 1994 | K943676 | DANEKSCOPE OPTI-PROBE | HRX | Substantially Equivalent | Danek Medical, Inc. | accessdata.fda.gov |
| September 7, 1994 | K943976 | SABRE ULTIMATE SHIELDED TROCAR | GCJ | Substantially Equivalent | Endoscopic Concepts, Inc. | accessdata.fda.gov |
| March 16, 1994 | K934738 | AUTOSUTURE ENDOSCOPIC SUTURING DEVICE | OCW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| February 17, 1994 | K935086 | AUTO SUTURE DISPOSABLE OPTICAL TROCAR | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| January 26, 1994 | K935426 | PREPERITONEAL DISTENTION BALLOON SYSTEM | GCJ | Substantially Equivalent | Origin Medsystems, Inc. | accessdata.fda.gov |
| December 17, 1993 | K930591 | TI-CRON AND DACRON SUTURES | GAT | Substantially Equivalent | Davis & Geck, Inc. | accessdata.fda.gov |
| December 17, 1993 | K930589 | PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR | GAL | Substantially Equivalent | Davis & Geck, Inc. | accessdata.fda.gov |
| July 9, 1993 | K924011 | ORIGIN BLUNT TIP SURGICAL TROCAR | GCJ | Substantially Equivalent | Origin Medsystems, Inc. | accessdata.fda.gov |
| February 1, 1993 | K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | GCI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| January 26, 1993 | K925149 | AUTO SUTURE ENDOSCOPIC KNOT PUSHER | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | 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 |
| September 27, 1991 | K912973 | ENDOSCOPE SUTURE & CARRIER | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| April 19, 1991 | K905035 | AXOSTIM NERVE STIMULATOR, MODIFICATION | ETN | Substantially Equivalent | Singer Medical Products, Inc. | accessdata.fda.gov |
| December 24, 1990 | K904588 | AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP | GAL | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| August 9, 1990 | K903419 | MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE | GDH | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| July 5, 1990 | K900531 | NONABSORBABLE NYLON SURGICAL SUTURE* | GAR | Substantially Equivalent for Some Indications | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| April 4, 1990 | K900123 | AUTO SUTURE SURGIPORT SPIRAL SLEEVE | FBQ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| August 22, 1989 | K885018 | ABSORBABLE SURGICAL GUT SUTURE* | GAL | Substantially Equivalent for Some Indications | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| June 27, 1979 | K790915 | JUHN TYM-TAP | FMH | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| October 17, 1978 | K781529 | SEPTAL BUTTON | LFB | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
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Updated May 28, 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.