Data / Medical devices / Turkey / Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi: FDA-registered device maker in Cankaya Ankara, Turkey, 118 510(k) clearances and 1 PMA approval
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi is registered with the FDA (registration 3014279513) in Cankaya Ankara, Turkey. It lists 71 device types. The FDA files 118 510(k) clearances and 1 PMA approval under its listings, the newest dated June 14, 2024. Registered through 2027. FDA data exported November 3, 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
- 3014279513
- Address
- Ilkbahar Mahallesi 620 Sokak No 5, Cankaya Ankara, Turkey, 06550
- Owner or operator
- MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI (10057109)
- Roles
- Exporter to the US
- First device listed
- February 23, 2018
- Registered through
- 2027
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 118.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 14, 2024 | K241250 | 3DMax Light Mesh | FTL | Substantially Equivalent | Davol Inc., Subsidiary of C. R. Bard, Inc. | accessdata.fda.gov |
| August 29, 2023 | K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) | FZP | Substantially Equivalent | Ethicon Endo Surgery, LLC | accessdata.fda.gov |
| February 17, 2023 | K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 22, 2022 | K220540 | ProGrip Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 5, 2022 | K221013 | GIA Auto Suture Stapler with DST Series Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 31, 2020 | K193237 | Carto Octaray Mapping Catheter with Trueref Technology | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 24, 2020 | K193579 | PlasmaBlade X 3.0S LIGHT | GEI | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| January 24, 2019 | K183346 | FLOW 90 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | 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 |
| February 15, 2018 | K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip | LKF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 29, 2017 | K172342 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 31, 2017 | K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component | OQY | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 10, 2017 | K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 5, 2017 | K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| September 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 31, 2016 | K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 26, 2016 | K160176 | Signia Stapler | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 28, 2016 | K153186 | Adjustable Fixation Device | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| November 24, 2015 | K151191 | OES ELITE Telescopes, Protective Tube | FBP | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| November 20, 2015 | K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | HET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| October 2, 2015 | K152526 | Elecsys Progesterone III CalSet | JIT | Substantially Equivalent | Roche Diagnostics | accessdata.fda.gov |
| September 14, 2015 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 20, 2015 | K143354 | Natrelle 133 Plus Tissue Expander | LCJ | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| July 2, 2015 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 16, 2014 | K143284 | Elecsys Estradiol III Calcheck | JJX | Substantially Equivalent | Roche Diagnostics | 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 |
| September 15, 2014 | K141122 | HARMONIC SCALLOP BLADE, GENERATOR G11 | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| August 12, 2014 | K141225 | ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 9, 2014 | K131855 | PENTAX VIDEO COLONOSCOPES (EC FAMILY) | FDF | Substantially Equivalent | Pentax Medical Company | accessdata.fda.gov |
| February 28, 2014 | K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 3, 2013 | K133314 | HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| November 27, 2013 | K132658 | HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS | FZP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| October 22, 2013 | K133128 | IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | 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 |
| October 3, 2013 | K131435 | ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| June 19, 2013 | K130819 | CLL- V1 LIGHT SOURCE | NTN | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 2, 2013 | K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER | KDI | Substantially Equivalent | Gambro Renal Products, Inc. | accessdata.fda.gov |
| April 3, 2013 | K130423 | THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 | FET | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 29, 2013 | K130653 | ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| March 1, 2013 | K121430 | EVOLUTION BILIARY STENT SYSTEM | FGE | Unknown | Cook Ireland, Ltd. | 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 1, 2012 | K122511 | ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| September 20, 2012 | K121724 | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 | FCW | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 30, 2012 | K122353 | CRAINFIX 2 TITANIUM CLAMP SYSTEM | GXN | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 22, 2012 | K121550 | HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| June 29, 2012 | K120897 | PROGRIP LAPARSCOPIC SELF-FIXATING MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| June 27, 2012 | K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| May 10, 2012 | K121279 | ELECSYS LH CALCHECK 5 | JJX | Substantially Equivalent | Roche Diagnostics | accessdata.fda.gov |
| January 31, 2012 | K112526 | TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS | MBI | Substantially Equivalent | Smith & Nephew, 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 |
| June 24, 2011 | K111513 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| April 28, 2011 | K103683 | IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| March 25, 2011 | K110699 | LIGAMAX 5 | FZP | Substantially Equivalent | Ethicon Endo-Sugery, LLC | accessdata.fda.gov |
| March 23, 2011 | K101928 | VENTRALEX ST HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 2, 2011 | K110009 | ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE | DQX | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| November 23, 2010 | K102904 | ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| November 10, 2010 | K103052 | V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE | GAT | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| October 5, 2010 | K101856 | ELECSYS CEA CALCHECK 5 | JJX | Substantially Equivalent | Roche Diagnostics | 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 13, 2010 | K093695 | PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE | GEI | Substantially Equivalent | Peak Surgical, Inc. | 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 |
| December 8, 2009 | K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 | FTL | Substantially Equivalent | Davol Inc., Sub. C. R. Bard, Inc. | accessdata.fda.gov |
| November 12, 2009 | K093408 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| September 14, 2009 | K091968 | KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C | FCW | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 1, 2009 | K091322 | CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| May 14, 2009 | K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | OCW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 26, 2009 | K082662 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, Tyco Healthcare Group LP | accessdata.fda.gov |
| December 19, 2008 | K082813 | STRYKER LED LIGHTSOURCE | FCW | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| August 6, 2008 | K082054 | GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| June 26, 2008 | K081146 | ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | 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 |
| May 21, 2008 | K072904 | SONOCA 180/195 WOUND CARE SYSTEM | LFL | Substantially Equivalent | Soering GmbH | accessdata.fda.gov |
| April 23, 2008 | K080358 | PLLA, HA SCREW | HWC | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| April 2, 2008 | K080715 | ERBE VIO ESU, MODEL VIO 200 S | GEI | Substantially Equivalent | Erbe USA, Inc. | accessdata.fda.gov |
| September 28, 2007 | K071920 | AUTOSUTURE ABSORBABLE TACK AND APPLICATOR | GDW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| October 10, 2006 | K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER | MRD | Substantially Equivalent | Mentor Corporation | accessdata.fda.gov |
| October 10, 2006 | K062209 | BASX BLADELESS TROCAR | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, LLC | 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 |
| March 16, 2006 | K060484 | ERBE VIO ESU, MODEL VIO 300 D | GEI | Substantially Equivalent | Erbe USA, Inc. | accessdata.fda.gov |
| February 16, 2006 | K060170 | ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | Erbe USA, Inc. | accessdata.fda.gov |
| November 23, 2004 | K043095 | ROCHE DIAGNOSTICS ELECSYS AFP CALSET II | JIT | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
| October 29, 2004 | K042793 | ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) | OWB | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| October 7, 2004 | K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS | KDI | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
| July 12, 2004 | K041413 | XPS 3000 SYSTEM | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| March 16, 2004 | K040505 | ZILVER 635 BILIARY STENT | FGE | Unknown | Cook, Inc. | accessdata.fda.gov |
| February 20, 2004 | K040212 | TRIGEN INTERTAN | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 5, 2002 | K020779 | PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | 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 |
| November 1, 2001 | K003957 | DIACLEAR ULTRAFILTER | FIP | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
| August 10, 2001 | K011496 | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 | FBO | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| February 21, 2001 | K003792 | STRYKER HEATED INSUFFLATOR TUBE SET | HIF | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| February 14, 2001 | K010237 | ELECSYS HCG+B CALCHECK | JJX | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
| January 26, 2001 | K003409 | ELECSYS FSH CALSET II | JIT | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
| June 5, 2000 | K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 | FGA | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 3, 1999 | K990619 | RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE | BTR | Substantially Equivalent | Rusch Intl. | accessdata.fda.gov |
| December 24, 1998 | K983559 | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR | FJK | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| July 9, 1998 | K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | MDM | 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 26, 2006 | P050038 | ARISTA AH ABSORBABLE HEMOSTAT | LMG | 40 | July 15, 2026 | accessdata.fda.gov |
Compare with other makers
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- All makers of Laparoscope, General & Plastic Surgery
Updated July 15, 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.