FDA Device Registration & Listing · Tarnowo Podgorne Wielkopolskie, PL · Registration 3007699067
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2018-01-26 |
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-04-09 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2025-04-09 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4150 | 2013-07-29 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2013-10-23 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-20 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4160 | 2007-12-03 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-09-11 |
| PXU | Fluid Drainage Tray | General, Plastic Surgery | Class 1 | 878.4200 | 2020-08-20 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2022-09-12 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2022-09-12 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2011-05-05 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2006-12-29 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2006-12-29 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-08-20 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2020-08-20 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3027454635 | LiNA Medical ApS | Naerum Hovedstaden, DK |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K935716 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE | 1995-11-16 |
| K951723 | GE Medical Systems | GE B510 TRANSDUCER | 1995-11-14 |
| K903562 | Diasonics, Inc. | CW DOPPLER 2.25 MHZ PROBE | 1992-03-02 |
| K945318 | Tetra Corp. | TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA | 1995-05-05 |
| K231666 | FUJIFILM Healthcare Americas Corporation | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | 2023-12-13 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0009-2022 | DJO, LLC | 2 | GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description:
2073/ INTELECT RPW 120V,
2073-BR/ INTELECT RPW 120V BRAZIL,
2074/ INTELECT RPW 230 V,
2082/ INTELECT RPW 100 V,
2760/ INTELECT LEGEND XT COMBOUS STD,
2791/ INTELECT LEGEND XT COMBO US STD W/CART,
2782-10/ INTELECT TRANSPORT US STD,
2782-2/ INTELECT TRANSPORT US STD,
2843/ INTELECT VET 4CH COMBO PKG,
2845K/ KIT INTELECT VET 4CH COMBO PKG,
2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM,
2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL,
2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL,
2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD,
2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL,
2792/ VECTRA GENISYS 2CH COMBO US STD W/CART,
2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL,
2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL,
2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL,
2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL,
2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL,
2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL,
2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART,
2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL,
2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL,
2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL,
2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL,
2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL,
2796/ VECTRA GENISYS 4CH COMBO US STD W/CART,
2796K/ KIT VECTRA GENISYS 4CH COMBO P,
2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL,
2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL,
2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL,
2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL,
2738/ INTELECT TRANSPORT COMBO PKG US STD,
8250KP/ KIT TRITON DTS PROMO,
6001/ INTELECT NEO,
2738-10/ INTELECT TRANSPORT COMBO PKG US STD,
2738-2/ INTELECT TRANSPORT COMBO PKG US STD,
2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD,
2776/ INTELECT MOBILE INT'L STD 5CM APPL,
27800/ ULTRASOUND ON CART,
2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL,
2776-10/ INT MOBIL INT'L STD 10CM APPL,
2776-2/ INT MOBILE INT'L STD 2CM APPL,
2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL,
2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL,
2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL,
2752CC/ INT ADV 2CH COLOR COMBO INT'L STD,
2756/ INTELECT VET 2CH COMBO PKG INT'L STD,
2844K/ KIT INTELECT VET 2CH COMBO PKG,
2782/ INTELECT TRANSPORT US STD,
2895K/ KIT CART ADAPT BL W/CT/SPEC US,
2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD,
2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART,
2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD,
2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART,
7550/ INT LEGEND COMBO 4C US STD,
INT001/ INTELECT LEGEND ULTRASOUND US STD,
INTC B/ INT CB PKGD US STD,
39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO,
39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO,
13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES,
15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG,
15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS,
15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG,
15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS,
2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG,
2174KIT/ INTELECT RPW 2 230V KIT EU PLUG,
2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG,
2176KIT/ INTELECT RPW 2 120V USA KIT,
12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD,
2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD,
70002/ NEO MODULE ULTRASOUND |
| Z-0010-2022 | DJO, LLC | 2 | Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits: |
| Z-0029-2022 | Aesthetics Systems Usa Inc | 2 | Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue. |
| Z-0038-2026 | ImaCor Inc. | 2 | ClariTEE Miniaturized TEE probe. Model Number: CLT-010.
Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH. |
| Z-0020-2023 | Hobbs Medical, Inc. | 2 | Hobbs Posi-Stop Injection Needle
Catalog Number: 4702 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3014407293 | POLYGON MEDICAL, INC. | Manalapan, NJ, US |
| 3028536560 | ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD | Hangzhou Zhejiang, CN |
| 3015972753 | STERISERVICE SP. Z O.O. | Czestochowa Slaskie, PL |
| 9611612 | PAJUNK GMBH MEDIZINTECHNOLOGIE | GEISINGEN Baden-Wurttemberg, DE |
| 3033902430 | OMEC THAI CO.,LTD. | Bang Bo District Samut Prakan, TH |
3007699067 when referencing this establishment in official correspondence.