Data / Medical devices / Turkey / Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi: FDA-registered device maker in Istanbul, Turkey, 108 510(k) clearances and 1 PMA approval
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi is registered with the FDA (registration 3014479313) in Istanbul, Turkey. It lists 52 device types. The FDA files 108 510(k) clearances and 1 PMA approval under its listings, the newest dated August 30, 2023. Registered through 2027. 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
- 3014479313
- Address
- NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey, Istanbul, Turkey, 34758
- Owner or operator
- SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI (10089530)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 14, 2023
- Registered through
- 2027
- Brand names listed
- ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE, ABSORBATACK FIXATION DEVICES, ADT FLEX TRACH W TG CUFF, AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH, AUTO SUTURE SURGICAL STAPLES, AUTO SUTUREMENDOSCOPIC CLAMP, AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE, AUTOSUTURE PROTACK; TACKER 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. Newest 100 of 108.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 30, 2023 | K223130 | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) | BTR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 23, 2023 | K223158 | LigaSure XP Maryland Jaw Sealer/Divider | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 2, 2022 | K223218 | Parietene Macroporous Mesh | FTL | Substantially Equivalent | Sofradim Production | 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 |
| June 27, 2022 | K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 22, 2022 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| March 21, 2022 | K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| November 15, 2021 | K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 17, 2021 | K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | CCK | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 30, 2021 | K210377 | Stryker iBur hubs and cutting accessories | HBE | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| March 23, 2021 | K202917 | LigaSure Exact Dissector, Nano-coated | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 2, 2020 | K202552 | Midas Rex Attachments and Dissecting Tools | OLO | Substantially Equivalent | Medtronic Powered Surgical Solutions (Mpss) | accessdata.fda.gov |
| December 6, 2019 | K192443 | Dextile Anatomical Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| May 12, 2019 | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | HBC | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| March 22, 2019 | K182861 | Shiley Neonatal/Pediatric Tracheostomy Tube | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 2, 2018 | K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | GEI | Substantially Equivalent | Medtronic Advanced Energy | accessdata.fda.gov |
| June 21, 2018 | K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 26, 2018 | K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 9, 2018 | K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| February 20, 2018 | K173270 | Tri-Staple 2.0 Reinforced Reload | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 27, 2017 | K171979 | Tubing Pack | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 15, 2017 | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools | HBC | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| April 21, 2017 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | GEI | 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 |
| January 17, 2017 | K161514 | Precision Thin Reciprocating Blade, 0.010in. | EQJ | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 18, 2016 | K162584 | VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 16, 2016 | K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | 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 |
| August 12, 2016 | K160331 | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 26, 2016 | K160176 | Signia Stapler | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 14, 2015 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 14, 2015 | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 2, 2015 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 18, 2015 | K151356 | Spacemaker Pro Access and Dissector System | GCJ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| February 24, 2015 | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 27, 2015 | K142929 | Ligasure Blunt Tip Sealer/Divider | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 14, 2014 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 28, 2014 | K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| June 26, 2014 | K140588 | FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS | FXY | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| April 9, 2014 | K140609 | RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 13, 2013 | K132441 | BARD VENTRALEX HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 3, 2013 | K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR | GEI | Substantially Equivalent | Medtronic Advanced Energy, LLC | accessdata.fda.gov |
| August 22, 2013 | K131969 | SYMBOTEX(TM) COMPOSITE MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| August 7, 2013 | K130608 | QUADCUT | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | 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 |
| October 23, 2012 | K123109 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | GDW | Substantially Equivalent | Covidien | 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 |
| October 9, 2012 | K122531 | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 5, 2012 | K113572 | LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER | GEI | Substantially Equivalent | Covidien, Formerly Valleylab, A Division 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 9, 2011 | K111887 | CLOSUREFAST RADIOFREQUENCY CATHETER | GEI | Substantially Equivalent | Covidien | 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 |
| November 10, 2010 | K103052 | V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE | GAT | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| May 10, 2010 | K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| April 22, 2010 | K100959 | SPECIMEN RETRIEVAL SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| April 13, 2010 | K093695 | PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE | GEI | Substantially Equivalent | Peak Surgical, Inc. | accessdata.fda.gov |
| May 14, 2009 | K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | OCW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 22, 2009 | K091087 | MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, Tyco Healthcare Group LP | accessdata.fda.gov |
| April 10, 2009 | K083519 | AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS | GDW | Substantially Equivalent | Covidien Lp, Formerly Registered AS United States | accessdata.fda.gov |
| April 3, 2009 | K090352 | TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 9, 2009 | K090419 | SILS STITCH ENDOSCOPIC SUTURING DEVICE | OCW | Substantially Equivalent | Covidien Lp, Formerly Registered AS United States | accessdata.fda.gov |
| September 5, 2008 | K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| June 13, 2008 | K080519 | PRISMAFLEX M150 SET | KDI | Substantially Equivalent | Gambro Renal Products, Inc. | accessdata.fda.gov |
| May 28, 2008 | K081050 | PARIETEX PROGRIP MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| November 30, 2007 | K073017 | STRYKER STRI-SHIELD FLYTE TOGAS | FYA | Substantially Equivalent | Stryker Instruments, Instruments Div. | accessdata.fda.gov |
| September 20, 2007 | K071859 | STRYKER CROSSFIRE SYSTEM | GEI | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| September 18, 2007 | K072315 | MIDAS REX CURVED BUR | HBE | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| June 29, 2007 | K071066 | SPYCATCH STONE RETRIEVAL BASKET | LQR | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| March 23, 2007 | K063005 | STRYKER T6 HOODS AND TOGAS | FYA | Substantially Equivalent | Stryker Instruments | 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 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 |
| August 1, 2006 | K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 | GEI | Substantially Equivalent | Vnus Medical Technologies, Inc. | accessdata.fda.gov |
| June 16, 2005 | K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| January 5, 2005 | K043273 | LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS | GEI | Substantially Equivalent | Valleylab | accessdata.fda.gov |
| September 24, 2004 | K042412 | MODIFIED SPACEMAKER SYSTEM | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| July 12, 2004 | K041413 | XPS 3000 SYSTEM | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| August 8, 2003 | K032117 | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | DZI | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| March 18, 2002 | K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM | HBB | Substantially Equivalent | Medtronic Midas Rex | accessdata.fda.gov |
| December 19, 2001 | K013860 | AUTO SUTURE SURGICAL STAPLES | GDW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| August 15, 2001 | K002992 | DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 | IKT | Substantially Equivalent | Medtronic Functional Diagnostics A/S | accessdata.fda.gov |
| June 12, 2000 | K001284 | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| November 6, 1998 | K982575 | MESH, SURGICAL, POLYMERIC | FTL | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| July 9, 1998 | K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | MDM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 4, 1996 | K963901 | ELECTROSURGICAL PROBE | GEI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| October 4, 1996 | K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| March 13, 1996 | K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| January 30, 1996 | K954483 | STRYKER SAGITTAL SAW ATTACHMENT | GFA | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| May 3, 1995 | K951589 | MANUAL SURGICAL INSRUMENT | GEI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| February 27, 1995 | K945407 | SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT | BTO | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| November 30, 1994 | K943540 | SURGICAL CUTTING BURS | DZJ | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| May 13, 1994 | K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | ETN | Substantially Equivalent | Xomed-Treace, 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 |
| January 31, 1994 | K935762 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE | 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 |
| 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 |
| September 17, 1992 | K920068 | AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | 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 |
|---|---|---|---|---|---|---|
| May 28, 1993 | P900056 | ROTABLATOR(R) | MCX | 219 | October 21, 2026 | accessdata.fda.gov |
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Updated October 21, 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.