ArtUs
Telemed
TELEMED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1222168 | 1222168 | TeleMed Systems | 1 | N | 2026-01-01 | 44 Bearfoot Rd Ste 200 Northborough MA US 01532 |
| 3007994837 | 3007994837 | TELEMED | 1 | N | 2026-01-01 | Savanoriu pr. 178A Highway Business Centre Vilnius Vilniaus Apskritis LT LT-03154 |
| 1222168 | 1222168 | TELEMED SYSTEMS, INC. | 1 | Y | 2020-04-25 | 8 KANE INDUSTRIAL DR. HUDSON MA US 01749 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 282639 | 1637485675 | K992402 | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH | KNS | 1999-12-22 |
| 42797 | 1699448071 | K992402 | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH | KNS | 1999-12-22 |
| 42797 | 1450245650 | K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD | KGE | 1999-12-22 |
| 282639 | 1980066038 | K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD | KGE | 1999-12-22 |
| 282639 | 1838902504 | K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR | KNW | 1998-01-21 |
| 42797 | 1876979563 | K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR | KNW | 1998-01-21 |
| 42797 | 1910310925 | K974300 | TELEMED SYSTEMS RETRIEVAL BASKET | OCZ | 1997-12-19 |
| 282639 | 2042144503 | K974300 | TELEMED SYSTEMS RETRIEVAL BASKET | OCZ | 1997-12-19 |
| 282639 | 1557863474 | K945295 | LSVP INTERNATIONAL GRASPING FORCEPS | LQR | 1995-03-08 |
| 42797 | 1896519813 | K945295 | LSVP INTERNATIONAL GRASPING FORCEPS | LQR | 1995-03-08 |
| 282639 | 1387350926 | K901439 | DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN | FEB | 1990-06-11 |
| 42797 | 1600757936 | K901439 | DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN | FEB | 1990-06-11 |
| 42797 | 1488898609 | K901438 | SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE | GAA | 1990-05-24 |
| 282639 | 1645693952 | K901438 | SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE | GAA | 1990-05-24 |
| 42797 | 1201657036 | K901437 | TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE | FBK | 1990-06-18 |
| 282639 | 1275423924 | K901437 | TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE | FBK | 1990-06-18 |
| 282639 | 1636286251 | K901436 | BRONCHIAL CYTOLOGY BRUSH | FDX | 1990-06-18 |
| 42797 | 1644552131 | K901436 | BRONCHIAL CYTOLOGY BRUSH | FDX | 1990-06-18 |
| 42797 | 1282564405 | K901435 | GASTROINTESTINAL CYTOLOGY BRUSH | FDX | 1990-07-16 |
| 282639 | 2031200990 | K901435 | GASTROINTESTINAL CYTOLOGY BRUSH | FDX | 1990-07-16 |
| 282639 | 1000266885 | K901432 | BILIARY BALLOON DILATOR | FGE | 1990-06-21 |
| 42797 | 1890662662 | K901432 | BILIARY BALLOON DILATOR | FGE | 1990-06-21 |
| 42797 | 1621930058 | K901431 | TELEMED ERCP CANNULA | FGE | 1990-06-18 |
| 282639 | 1879780567 | K901431 | TELEMED ERCP CANNULA | FGE | 1990-06-18 |
| 42797 | 1092724446 | K901429 | SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE | OCY | 1990-06-05 |
| 282639 | 1730963514 | K901429 | SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE | OCY | 1990-06-05 |
| 42797 | 1891452444 | K901428 | DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE | FDI | 1990-06-18 |
| 282639 | 2057238606 | K901428 | DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE | FDI | 1990-06-18 |
| 42797 | 1716974960 | K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON | FGE | 1990-06-22 |
| 282639 | 2046166418 | K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON | FGE | 1990-06-22 |
| 42797 | 1848869283 | K901424 | ESOPHAGEAL BALLOON DILATOR | KNQ | 1990-06-21 |
| 282639 | 1941097897 | K901424 | ESOPHAGEAL BALLOON DILATOR | KNQ | 1990-06-21 |
| 139635 | 1974179772 | K211248 | ArtUs | IYN | 2022-02-11 |
| 139635 | 1177977487 | K163121 | SmartUs EXT-1M/3M | IYN | 2017-08-10 |
| 139635 | 1129375006 | K161968 | MicrUs | IYO | 2016-11-03 |
| 139635 | 1759841752 | K113184 | LOGICSCAN 64 LOGICSCAN 128 | IYN | 2012-01-26 |
| 139635 | 1081298364 | K102253 | ECHO BLASTER | IYO | 2011-03-14 |
| 42797 | 1384654180 | K020379 | PPD BALLOON DILATATION CATHETER | KNT | 2002-05-06 |
| 282639 | 1860864528 | K020379 | PPD BALLOON DILATATION CATHETER | KNT | 2002-05-06 |
| 42797 | 1203195471 | K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON | FGE | 2002-03-01 |
| 282639 | 1983149596 | K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON | FGE | 2002-03-01 |
| 42797 | 1485146296 | K010412 | FLEXIBLE ENDOSCOPIC SCISSORS | OCZ | 2001-04-02 |
| 282639 | 1488012638 | K010412 | FLEXIBLE ENDOSCOPIC SCISSORS | OCZ | 2001-04-02 |
| 42797 | 1299855122 | ||||
| 42797 | 1331512323 | ||||
| 42797 | 1357300167 | ||||
| 42797 | 1448254132 | ||||
| 42797 | 1585987300 | ||||
| 42797 | 1928729905 | ||||
| 42797 | 1966615492 | ||||
| 42797 | 1968642709 | ||||
| 282639 | 1162237879 | ||||
| 282639 | 1238180886 | ||||
| 282639 | 1240824150 | ||||
| 282639 | 1464170935 | ||||
| 282639 | 1506875242 | ||||
| 282639 | 1748756973 | ||||
| 282639 | 1837175512 | ||||
| 282639 | 1996385352 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FGE | 8 | 2002-03-01 |
| OCZ | 4 | 2001-04-02 |
| FDX | 4 | 1990-07-16 |
| IYN | 3 | 2022-02-11 |
| IYO | 2 | 2016-11-03 |
| KNT | 2 | 2002-05-06 |
| KNS | 2 | 1999-12-22 |
| KGE | 2 | 1999-12-22 |
| KNW | 2 | 1998-01-21 |
| LQR | 2 | 1995-03-08 |
| KNQ | 2 | 1990-06-21 |
| FBK | 2 | 1990-06-18 |
| FDI | 2 | 1990-06-18 |
| FEB | 2 | 1990-06-11 |
| OCY | 2 | 1990-06-05 |
| GAA | 2 | 1990-05-24 |
PMN#
SmartUs EXT-1M/3M
TELEMED
MicrUs
TELEMED
TM ECloud ECG Analysis System
Telemed Solutions, Inc.
LOGICSCAN 64 LOGICSCAN 128
TELEMED
TELEMEDCARE HEALTH MONITOR
TELEMEDCARE PTY LTD
ECHO BLASTER
TELEMED
VITALLINK3 MOBILE VITAL SIGNS SYSTEM
TELEMEDIC SYSTEMS LTD
PPD BALLOON DILATATION CATHETER
TELEMED SYSTEMS, INC.
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
TELEMED SYSTEMS, INC.
VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
TELEMEDIC SYSTEMS, INC.
FLEXIBLE ENDOSCOPIC SCISSORS
TELEMED SYSTEMS, INC.
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
TELEMED SYSTEMS, INC.
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
TELEMED SYSTEMS, INC.
REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR
TELEMED SYSTEMS, INC.
TELEMED SYSTEMS RETRIEVAL BASKET
TELEMED SYSTEMS, INC.
GASTROINTESTINAL CYTOLOGY BRUSH
TELEMED SYSTEMS, INC.
BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
TELEMED SYSTEMS, INC.
SURE-FLEX ANASTOMOTIC BALLOON DILATOR
TELEMED SYSTEMS, INC.
BILIARY BALLOON DILATOR
TELEMED SYSTEMS, INC.
COLONIC BALLOON DILATOR
TELEMED SYSTEMS, INC.
ESOPHAGEAL BALLOON DILATOR
TELEMED SYSTEMS, INC.
PYLORIC BALLOON DILATOR
TELEMED SYSTEMS, INC.
BRONCHIAL CYTOLOGY BRUSH
TELEMED SYSTEMS, INC.
TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE
TELEMED SYSTEMS, INC.
TELEMED ERCP CANNULA
TELEMED SYSTEMS, INC.
DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE
TELEMED SYSTEMS, INC.
DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN
TELEMED SYSTEMS, INC.
PAPILLOTOME
TELEMED SYSTEMS, INC.
SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE
TELEMED SYSTEMS, INC.
SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE
TELEMED SYSTEMS, INC.
OMNIGRAPH 6000
TELEMED DIV.
OMNIGRAPH 4000(ELECTROCARDIOGRAPH)
TELEMED DIV.
GUDID#
Disposable Sure-Flex Biliary Balloon Dilatation Catheter - Biliary Dilator6mm Diameter x 2cm Length Balloon Dimension180cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Biliary Balloon Dilatation Catheter - Biliary Dilator8mm Diameter x 4cm Length Balloon Dimension180cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Biliary Balloon Dilatation Catheter - Biliary Dilator10mm Diameter x 8cm Length Balloon Dimension180cm Total Catheter Length
2023-07-12
Disposable Progressive Pressure Dilators - PPD Gastrointestinal Dilator15-17mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
Disposable Progressive Pressure Dilators - PPD Gastrointestinal Dilator18-20mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
ArtUs - Ultrasound Transducer curved array
2024-08-09
Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 1.8mm Catheter Diameter x 200cm Length
2023-08-24
Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle23GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
2023-08-24
Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle23GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
2023-08-24
Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
2023-08-24
Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
2023-08-24
Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle21GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
2023-08-24
Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length x 230cm Working Length
2023-08-24
Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 240cm Working Length
2023-08-24
Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle23GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 240cm Working Length
2023-08-24
Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 160cm Working Length
2023-08-24
Disposable Transbronchial Needle - Sure-Stop Transbronchial Aspiration Needle21GA Needle Diameter x 1.8mm Sheath Diameter x 13mm Needle Length x 150cm Working Length
2023-08-24
Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 1.8mm Catheter Diameter x 160cm Length
2023-08-24
Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 1.8mm Catheter Diameter x 230cm Length
2023-08-24
Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 2.3mm Catheter Diameter x 160cm Length
2023-08-24
Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 2.3mm Catheter Diameter x 200cm Length
2023-08-24
Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 2.3mm Catheter Diameter x 230cm Length
2023-08-24
Disposable Bronchial Cytology Brush - Disposable Bronchial Cytology Brush2.0mm Brush Diameter x 1.8mm Catheter Diameter x 120cm Length
2023-08-24
Disposable Bronchial Cytology Brush - Disposable Bronchial Cytology Brush3.0mm Brush Diameter x 1.8mm Catheter Diameter x 120cm Length
2023-08-24
Disposable Duralon Occlusion Balloon - 2 Lumen - Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.5mm, 16.5mm, 20.0mm7fr Shaft Size x 200cm Catheter LengthStiff Shaft Style with Distal Injection Port
2023-07-19
Disposable Duralon Occlusion Balloon - 2 Lumen - Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.5mm, 16.5mm, 20.0mm7fr Shaft Size x 200cm Catheter LengthDistal Injection Port
2023-07-19
Disposable Duralon Occlusion Balloon - 2 Lumen - Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.0mm, 16.5mm, 20.0mm7fr to 5fr Shaft Size x 200cm Catheter LengthProximal Injection Port
2023-07-19
Disposable Duralon Occlusion Balloon - 2 Lumen - Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.0mm, 16.5mm, 20.0mm7fr to 5fr Shaft Size x 200cm Catheter LengthDistal Injection Port
2023-07-19
Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator16mm Diameter x 4cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator8mm Diameter x 8cm Length Balloon Dimensions200cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator16mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator18mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator12mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator10mm Diameter x 4cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator14mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator10mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
ArtUs - Ultrasound system, imaging, general-purpose, portable
2023-01-20
ArtUs - Ultrasound transducer, curved array.
2023-01-20
ArtUs - Ultrasound transducer convex array
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ArtUs - Ultrasound transducer linear array 40mm
2023-01-20