TELEMED SYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
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 table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
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
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
42797	1896519813	K945295	LSVP INTERNATIONAL GRASPING FORCEPS	LQR	1995-03-08
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
42797	1201657036	K901437	TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE	FBK	1990-06-18
42797	1644552131	K901436	BRONCHIAL CYTOLOGY BRUSH	FDX	1990-06-18
42797	1282564405	K901435	GASTROINTESTINAL CYTOLOGY BRUSH	FDX	1990-07-16
42797	1890662662	K901432	BILIARY BALLOON DILATOR	FGE	1990-06-21
42797	1621930058	K901431	TELEMED ERCP CANNULA	FGE	1990-06-18
42797	1092724446	K901429	SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE	OCY	1990-06-05
42797	1891452444	K901428	DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE	FDI	1990-06-18
42797	1716974960	K901427	BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON	FGE	1990-06-22
42797	1848869283	K901424	ESOPHAGEAL BALLOON DILATOR	KNQ	1990-06-21
42797	1384654180	K020379	PPD BALLOON DILATATION CATHETER	KNT	2002-05-06
42797	1203195471	K013737	MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON	FGE	2002-03-01
42797	1485146296	K010412	FLEXIBLE ENDOSCOPIC SCISSORS	OCZ	2001-04-02
42797	1299855122
42797	1331512323
42797	1357300167
42797	1448254132
42797	1585987300
42797	1928729905
42797	1966615492
42797	1968642709

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FGE	4	2002-03-01
OCZ	2	2001-04-02
FDX	2	1990-07-16
KNT	1	2002-05-06
KGE	1	1999-12-22
KNS	1	1999-12-22
KNW	1	1998-01-21
LQR	1	1995-03-08
KNQ	1	1990-06-21
FDI	1	1990-06-18
FBK	1	1990-06-18
FEB	1	1990-06-11
OCY	1	1990-06-05
GAA	1	1990-05-24

PMN#

PPD BALLOON DILATATION CATHETER
2002-05-06
TELEMED SYSTEMS, INC.
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
2002-03-01
TELEMED SYSTEMS, INC.
FLEXIBLE ENDOSCOPIC SCISSORS
2001-04-02
TELEMED SYSTEMS, INC.
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
1999-12-22
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
1999-12-22
TELEMED SYSTEMS, INC.
REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR
1998-01-21
TELEMED SYSTEMS, INC.
TELEMED SYSTEMS RETRIEVAL BASKET
1997-12-19
TELEMED SYSTEMS, INC.
GASTROINTESTINAL CYTOLOGY BRUSH
1990-07-16
TELEMED SYSTEMS, INC.
BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
1990-06-22
TELEMED SYSTEMS, INC.
SURE-FLEX ANASTOMOTIC BALLOON DILATOR
1990-06-21
TELEMED SYSTEMS, INC.
PYLORIC BALLOON DILATOR
1990-06-21
TELEMED SYSTEMS, INC.
ESOPHAGEAL BALLOON DILATOR
1990-06-21
TELEMED SYSTEMS, INC.
COLONIC BALLOON DILATOR
1990-06-21
TELEMED SYSTEMS, INC.
BILIARY BALLOON DILATOR
1990-06-21
TELEMED SYSTEMS, INC.
TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE
1990-06-18
TELEMED SYSTEMS, INC.
TELEMED ERCP CANNULA
1990-06-18
TELEMED SYSTEMS, INC.
DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE
1990-06-18
TELEMED SYSTEMS, INC.
BRONCHIAL CYTOLOGY BRUSH
1990-06-18
TELEMED SYSTEMS, INC.
DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN
1990-06-11
TELEMED SYSTEMS, INC.
PAPILLOTOME
1990-06-08
TELEMED SYSTEMS, INC.
SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE
1990-06-05
TELEMED SYSTEMS, INC.
SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE
1990-05-24
TELEMED SYSTEMS, INC.