510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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TeleMed Systems

Northborough, MA, US

TeleMed Systems appears in FDA device records in Northborough, MA. FDA records list 22 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
22
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to TeleMed Systems carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Shent USA, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 22 510(k) clearances for TeleMed Systems between 1990 and 2002. The busiest year on record is 1990, with 15. The most recent is 2002, with 2.

Clearances by year, as a table
510(k) clearance decisions for TeleMed Systems, by decision year
YearClearances
199015
19971
19981
19992
20011
20022
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K020379PPD BALLOON DILATATION CATHETERKNTSubstantially Equivalent
K013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOONFGESubstantially Equivalent
K010412FLEXIBLE ENDOSCOPIC SCISSORSOCZSubstantially Equivalent
K9924025.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCHKNSSubstantially Equivalent
K992390HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATDKGESubstantially Equivalent
K974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSARKNWSubstantially Equivalent
K974300TELEMED SYSTEMS RETRIEVAL BASKETOCZSubstantially Equivalent
K901435GASTROINTESTINAL CYTOLOGY BRUSHFDXSubstantially Equivalent
K901427BILIARY STONE RETRIEVAL AND OCCLUSION BALLOONFGESubstantially Equivalent
K901433SURE-FLEX ANASTOMOTIC BALLOON DILATORFGESubstantially Equivalent
K901432BILIARY BALLOON DILATORFGESubstantially Equivalent
K901426COLONIC BALLOON DILATORFFPSubstantially Equivalent
K901425PYLORIC BALLOON DILATORFATSubstantially Equivalent
K901424ESOPHAGEAL BALLOON DILATORKNQSubstantially Equivalent
K901437TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLEFBKSubstantially Equivalent
K901436BRONCHIAL CYTOLOGY BRUSHFDXSubstantially Equivalent
K901431TELEMED ERCP CANNULAFGESubstantially Equivalent
K901428DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNAREFDISubstantially Equivalent
K901439DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEANFEBSubstantially Equivalent
K901434PAPILLOTOMEKWSSubstantially Equivalent
K901429SOFT, SPRING TIPPED NYLON COATED GUIDE WIREOCYSubstantially Equivalent
K901438SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLEGAASubstantially Equivalent

Registered establishments

FDA registered establishments for TeleMed Systems, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12221681222168TeleMed Systems44 Bearfoot Rd Ste 200, Northborough, MA 01532 US2026and 12 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2230-2021Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscopeMislabeled: 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, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).Class IICompleted
Z-2229-2021Grasper/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 endoscopeMislabeled: 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, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).Class IICompleted

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain