Data / Medical devices / Turkey / Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun: FDA-registered device maker in ESENYURT Istanbul, Turkey, 4 510(k) clearances
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun is registered with the FDA (registration 3009482034) in ESENYURT Istanbul, Turkey. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 27, 2020. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3009482034
- Address
- No: 45/5 Akcaburgaz Mahallesi MUHSIN YAZICIOGLU CADDESI, ESENYURT Istanbul, Turkey, 34522
- Owner or operator
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler (10038506)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 19, 2011
- Registered through
- 2027
- Brand names listed
- 82 gr 113 gr 250 ml 1000 ml, ECG Gel 1000 ml, ECG Gel 250 ml, ECG Gel 500 ml, ECG Gel 5000 ml, GYNOTAL Obstetric Sterile Gel 12 ml, Joy Drops, KLY Non Sterile Lubricant Jelly 2.5 gr 3 gr 3.5 gr 4 gr 4.5 gr 5 gr 10 gr 42 gr 50 gr 62 gr 82 100 gr 113.4 gr 42 gr and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anti Fog Solution And Accessories, Endoscopy | OCT | 2 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph, Multi-Function | MLN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Manufacturer | accessdata.fda.gov |
| Media, Coupling, Ultrasound | MUI | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| August 27, 2020 | K190864 | Konix Anti-Fog Solution | OCT | Substantially Equivalent | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | accessdata.fda.gov |
| April 17, 2015 | K140506 | JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL | NUC | Substantially Equivalent | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | accessdata.fda.gov |
| June 18, 2014 | K130581 | KONIX STERILE GEL | MUI | Substantially Equivalent | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | accessdata.fda.gov |
| May 27, 2011 | K101952 | KONIX ULTRASOUND GEL | ITX | Substantially Equivalent | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 9, 2023 | 93580 | Class II | Ongoing | REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292 | Sterility of Ultrasound gel can not be guaranteed. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Electrode, Electrocardiograph, Multi-Function
- All makers of Media, Coupling, Ultrasound
- All makers of Lubricant, Patient
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Anti Fog Solution And Accessories, Endoscopy
Updated January 20, 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.