Data / Medical devices / United States / TeleMed Systems
TeleMed Systems: FDA-registered device maker in Northborough, MA, United States, 19 510(k) clearances
TeleMed Systems is registered with the FDA (registration 1222168) in Northborough, MA, United States. It lists 22 device types. The FDA files 19 510(k) clearances under its listings, the newest dated May 6, 2002. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1222168
- Address
- 44 Bearfoot Rd Ste 200, Northborough, MA, United States, 01532
- Owner or operator
- SHENT USA, INC. (10078923)
- Roles
- Specification developer
- First device listed
- November 10, 2020
- Registered through
- 2026
- Brand names listed
- Biopsy Forceps, Bronchial Cytology Brush, Carr-locke, forceps, retriever, DISPOSABLE GRASPING FORCEPS, DISPOSABLE RETRIEVAL BASKET, Duralon Occl. Balloon, 2 lumen, Duralon Occl. Balloon, 3 lumen, ERCP Cannulas 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 6, 2002 | K020379 | PPD BALLOON DILATATION CATHETER | KNT | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| March 1, 2002 | K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON | FGE | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| April 2, 2001 | K010412 | FLEXIBLE ENDOSCOPIC SCISSORS | OCZ | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| December 22, 1999 | 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 | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| December 22, 1999 | K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD | KGE | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| January 21, 1998 | K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR | KNW | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| December 19, 1997 | K974300 | TELEMED SYSTEMS RETRIEVAL BASKET | OCZ | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| March 8, 1995 | K945295 | LSVP INTERNATIONAL GRASPING FORCEPS | LQR | Substantially Equivalent | Lsvp Intl., Inc. | accessdata.fda.gov |
| July 16, 1990 | K901435 | GASTROINTESTINAL CYTOLOGY BRUSH | FDX | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| June 22, 1990 | K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON | FGE | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| June 21, 1990 | K901432 | BILIARY BALLOON DILATOR | FGE | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| June 21, 1990 | K901424 | ESOPHAGEAL BALLOON DILATOR | KNQ | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| June 18, 1990 | K901437 | TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE | FBK | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| June 18, 1990 | K901436 | BRONCHIAL CYTOLOGY BRUSH | FDX | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| June 18, 1990 | K901431 | TELEMED ERCP CANNULA | FGE | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| June 18, 1990 | K901428 | DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE | FDI | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| June 11, 1990 | K901439 | DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN | FEB | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| June 5, 1990 | K901429 | SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE | OCY | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
| May 24, 1990 | K901438 | SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE | GAA | Substantially Equivalent | Telemed Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 12, 2021 | 88136 | Class II | Completed | Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope | Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Al | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Catheter, Balloon Type
- All makers of Endoscopic Injection Needle, Gastroenterology-Urology
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Tubes, Gastrointestinal (And Accessories)
Updated May 6, 2002. 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.