Company ยท US
Telemed Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2002. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 5 |
| FDX | Endoscopic Cytology Brush | 2 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 2 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| FDI | Snare, Flexible | 1 |
| FEB | Accessories, Cleaning, For Endoscope | 1 |
| FFP | Dilator, Rectal | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| KGE | Forceps, Biopsy, Electric | 1 |
| KNQ | Dilator, Esophageal | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| KNW | Instrument, Biopsy | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 6, 2002 | K020379 | PPD BALLOON DILATATION CATHETER Telemed Systems, Inc. | KNT |
| Mar 1, 2002 | K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON Telemed Systems, Inc. | FGE |
| Apr 2, 2001 | K010412 | FLEXIBLE ENDOSCOPIC SCISSORS Telemed Systems, Inc. | OCZ |
| Dec 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 Telemed Systems, Inc. | KNS |
| Dec 22, 1999 | K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD Telemed Systems, Inc. | KGE |
| Jan 21, 1998 | K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR Telemed Systems, Inc. | KNW |
| Dec 19, 1997 | K974300 | TELEMED SYSTEMS RETRIEVAL BASKET Telemed Systems, Inc. | OCZ |
| Jul 16, 1990 | K901435 | GASTROINTESTINAL CYTOLOGY BRUSH Telemed Systems, Inc. | FDX |
| Jun 22, 1990 | K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON Telemed Systems, Inc. | FGE |
| Jun 21, 1990 | K901433 | SURE-FLEX ANASTOMOTIC BALLOON DILATOR Telemed Systems, Inc. | FGE |
| Jun 21, 1990 | K901432 | BILIARY BALLOON DILATOR Telemed Systems, Inc. | FGE |
| Jun 21, 1990 | K901426 | COLONIC BALLOON DILATOR Telemed Systems, Inc. | FFP |
| Jun 21, 1990 | K901425 | PYLORIC BALLOON DILATOR Telemed Systems, Inc. | FAT |
| Jun 21, 1990 | K901424 | ESOPHAGEAL BALLOON DILATOR Telemed Systems, Inc. | KNQ |
| Jun 18, 1990 | K901437 | TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE Telemed Systems, Inc. | FBK |
| Jun 18, 1990 | K901436 | BRONCHIAL CYTOLOGY BRUSH Telemed Systems, Inc. | FDX |
| Jun 18, 1990 | K901431 | TELEMED ERCP CANNULA Telemed Systems, Inc. | FGE |
| Jun 18, 1990 | K901428 | DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE Telemed Systems, Inc. | FDI |
| Jun 11, 1990 | K901439 | DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN Telemed Systems, Inc. | FEB |
| Jun 8, 1990 | K901434 | PAPILLOTOME Telemed Systems, Inc. | KWS |
| Jun 5, 1990 | K901429 | SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE Telemed Systems, Inc. | OCY |
| May 24, 1990 | K901438 | SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE Telemed Systems, Inc. | GAA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||