Data / Medical devices / Turkey / Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti: FDA-registered device maker in Istanbul, Turkey, 103 510(k) clearances and 3 PMA approvals
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti is registered with the FDA (registration 3011989923) in Istanbul, Turkey. It lists 87 device types. The FDA files 103 510(k) clearances and 3 PMA approvals under its listings, the newest dated May 9, 2024. 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
- 3011989923
- Address
- Oruc Reis Mahallesi Giyimkent 3 Sokak No 21A-23A Esenler, Istanbul, Turkey, 34235
- Owner or operator
- Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti (10060275)
- Roles
- Exporter to the US, Specification developer
- First device listed
- April 23, 2019
- Registered through
- 2026
- Brand names listed
- ACCESS AFP REAGENTS, ACCESS DHEA-S REAGENT ASSAY, ACCESS ESTRADIOL REAGENTS, ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY, ACCESS HYBRITECH P2PSA, ACCESS INTACT PTH AND CALIBRATORS, ACCESS PROGESTERONE ASSAY, ACCESS PROLACTIN ASSAY 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 103.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 9, 2024 | K240403 | Access BR Monitor | MOI | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 20, 2024 | K234052 | Access Ferritin | JMG | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 6, 2024 | K240273 | Access Free T4 | CEC | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| September 26, 2023 | K213517 | Access Thyroglobulin Antibody II | JZO | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| September 22, 2023 | K223921 | Access CEA | DHX | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| August 23, 2023 | K223590 | Access Folate Assay | CGN | Substantially Equivalent | Beckman Coulter, Inc. | 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 |
| February 8, 2023 | K223038 | Access Cortisol | CGR | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 13, 2023 | K223405 | Access Testosterone | CDZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 23, 2022 | K223289 | Access Vitamin B12 | CDD | Substantially Equivalent | Beckman Coulter, 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 |
| 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 |
| February 6, 2019 | K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| April 10, 2018 | K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | 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 |
| December 16, 2016 | K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | JGS | Substantially Equivalent | Beckman Coulter, Inc. | 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 18, 2016 | K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems | JLW | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 2, 2015 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors | MBI | Substantially Equivalent | Smith & Nephew, 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 |
| December 22, 2014 | K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst | MRG | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 19, 2014 | K142362 | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. | MRG | Substantially Equivalent | Beckman Coulter, Inc. | 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 21, 2014 | K141820 | JAGWIRE HIGH PERFORMANCE GUIDWIRE | OCY | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| October 15, 2014 | K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | DCF | Substantially Equivalent | Beckman Coulter Ireland, Inc. | accessdata.fda.gov |
| August 14, 2014 | K141153 | LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 16, 2014 | K133727 | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 13, 2013 | K132441 | BARD VENTRALEX HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, 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 |
| March 18, 2013 | K122059 | ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS | MBI | Substantially Equivalent | Smith & Nephew, 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 |
| February 20, 2013 | K123425 | TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 25, 2013 | K122797 | ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| January 20, 2012 | K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 20, 2012 | K112343 | TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS | LIP | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 4, 2011 | K112603 | ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS | JJX | Substantially Equivalent | Beckman Coulter, 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 |
| May 24, 2011 | K111153 | SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM | GDW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 25, 2011 | K110699 | LIGAMAX 5 | FZP | Substantially Equivalent | Ethicon Endo-Sugery, LLC | accessdata.fda.gov |
| May 14, 2010 | K100010 | HDL CHOLESTEROL (HDLX) ASSAY | LBS | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 7, 2010 | K093845 | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 | GDW | Substantially Equivalent | ETHICON, 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 10, 2008 | K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 21, 2008 | K082095 | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE | HTN | Substantially Equivalent | Smith & Nephew Endoscopy, 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 |
| May 23, 2008 | K081169 | AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS United States | accessdata.fda.gov |
| April 23, 2008 | K080358 | PLLA, HA SCREW | HWC | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| February 11, 2008 | K073490 | OLYMPUS IGG REAGENT | CFN | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 11, 2008 | K073489 | OLYMPUS IGA REAGENT | CFN | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 11, 2008 | K073487 | OLYMPUS IGM REAGENT | CFN | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| April 6, 2007 | K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | KNK | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| March 23, 2007 | K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | CDT | Substantially Equivalent | Olympus America, Inc. | 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 | K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | CJY | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| September 15, 2006 | K061190 | ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 | CEW | Substantially Equivalent | Beckman Coulter, Inc. | 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 |
| July 6, 2006 | K061382 | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 | JZO | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| June 6, 2006 | K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | DHR | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| January 23, 2006 | K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | NBC | Substantially Equivalent | Biosite Incorporated | accessdata.fda.gov |
| June 15, 2005 | K051326 | SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 12, 2004 | K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS | CEM | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| October 5, 2004 | K042651 | FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS | JIT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 16, 2004 | K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | JMO | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| June 7, 2004 | K041216 | SMITH & NEPHEW ULTRABRAID SUTURE | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 24, 2004 | K040181 | ACCESS DHEA-S REAGENT ASSAY | JKC | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| May 2, 2003 | K031297 | ACCESS OV MONITOR ASSAY | LTK | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| October 22, 2001 | K012777 | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS | JZO | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| February 5, 2001 | K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY | CGN | Substantially Equivalent | Bayer Diagnostics Corp. | accessdata.fda.gov |
| December 16, 1999 | K993571 | BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 | CDD | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| June 18, 1999 | K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | CDP | Substantially Equivalent | Chiron Diagnostics Corp. | accessdata.fda.gov |
| December 18, 1998 | K983536 | PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| July 14, 1998 | K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | CEC | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| April 1, 1998 | K980155 | ENDOBUTTON CONTINUOUS LOOP | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 31, 1997 | K973743 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | CHP | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| June 13, 1997 | K971253 | VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 14, 1997 | K963424 | OLYMPUS LIPASE REAGENT | CDT | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| January 9, 1997 | K965084 | VIDAS PROESTERONE (PRG) (30 409) | JLS | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 7, 1996 | K963286 | IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT | DAD | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| June 17, 1996 | K961510 | ACS FRT4 IMMUNOASSAY | JJX | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| February 5, 1996 | K955769 | ACCESS PROGESTERONE ASSAY | JLS | Substantially Equivalent | Bio-Rad Laboratories, 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 |
| October 20, 1995 | K954680 | ACCESS PROLACTIN ASSAY (MODIFICATION) | CFT | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| September 25, 1995 | K953084 | ACCESS ULTRASENSITIVE INSULIN ASSAY | CFP | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| May 3, 1995 | K951589 | MANUAL SURGICAL INSRUMENT | GEI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| December 27, 1994 | K944407 | OLYMPUS MAGNESIUM REAGENT | JGJ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| March 3, 1994 | K940005 | ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY | CGJ | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| February 5, 1993 | K925339 | OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT | CKA | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| January 26, 1993 | K925155 | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT | CIT | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| December 3, 1992 | K924964 | OLYMPUS TOTAL BILIRUBIN REAGENT | CIG | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| December 3, 1992 | K924601 | OLYMPUS GLUCOSE REAGENT | CFR | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| November 30, 1992 | K924963 | OLYMPUS DIRECT BILIRUBIN REAGENT | CIG | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| November 25, 1992 | K924693 | OLYMPUS BUN REAGENT | CDQ | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| November 18, 1992 | K925156 | OLYMPUS ALKALINE PHOSPHATASE REAGENT | CJE | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| October 19, 1992 | K924692 | OLYMPUS CREATININE REAGENT | CGX | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| October 19, 1992 | K924339 | OLYMPUS AMYLASE REAGENT | CIW | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| July 17, 1992 | K922369 | OLYMPUS ALBUMIN REAGENT | CIX | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| October 25, 1991 | K913646 | CIBA CORNING ACS T3 IMMUNOASSAY | CDD | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| April 30, 1991 | K910981 | CIBA CORNING ACS TSH IMMUNOASSAY | JLW | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| October 11, 1990 | K903205 | AUTO SUTURE(R) ENDOSCOPIC CLAMP | HDA | 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 26, 2005 | P030049 | ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL | LOM | 14 | March 11, 2021 | accessdata.fda.gov |
| December 22, 2004 | P030056 | ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS | MZO | 18 | April 27, 2021 | accessdata.fda.gov |
| February 8, 1999 | P980041 | ACCESS AFP IMMUNOASSAY SYSTEM | LOK | 47 | November 3, 2025 | accessdata.fda.gov |
Compare with other makers
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Updated May 9, 2024. 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.