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

Tel Aviv, IL

INSPIREMD, INC. appears in FDA device records in Tel Aviv, IL. FDA records list no 510(k) clearances, 3 PMA records and 2 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
3
Recall records
6
Registered establishments
2

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for INSPIREMD Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30328141193032814119INSPIREMD, INC.6303 Waterford District Dr Ste 215, Miami, FL 33126 US2026No device listings on this registration
30316588943031658894INSPIREMD, LTD.4 Menorat HaMaor Street, Tel Aviv 6744832 IL2026

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-2330-2026CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Class IIOpen, Classified
Z-2329-2026CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Class IIOpen, Classified
Z-2328-2026Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Class IIOpen, Classified
Z-2327-2026CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Class IIOpen, Classified
Z-2326-2026Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Class IIOpen, Classified
Z-2325-2026Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Class IIOpen, Classified

Verification record

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