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

Rehovot Central, IL

PI-CARDIA LTD appears in FDA device records in Rehovot Central, IL. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

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

510(k) clearance history

FDA records hold 1 510(k) clearance for PI-Cardia Ltd in 2024.

Clearances by year, as a table
510(k) clearance decisions for PI-Cardia Ltd, by decision year
YearClearances
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
DEN240017ShortCutSCZUnknown

Registered establishments

FDA registered establishments for PI-Cardia Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30304715253030471525PI-CARDIA LTDDavid Fikes 5, Rehovot Central 7632805 IL2026
30333075373033307537Pi-Cardia Inc1 Broadway Ct, Cambridge, MA 02138 US2026

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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