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

Cranston, RI, US

Cadence Inc. appears in FDA device records in Cranston, RI. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

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

FDA records under these names

1 name

FDA records resolved to Cadence Inc. 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.

  • Cadence Science, Inc.registration, enforcement report, recall

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 Cadence Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30092667513009266751Cadence Inc.9 Technology Dr, Staunton, VA 24401 US2026
12136491213649Cadence Science, Inc.2080 PLAINFIELD PIKE, Cranston, RI 02921 US2026

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-0365-2020Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital UseThe glass syringe used with Pressure Control Syringes may potentially break during use.Class IITerminated
Z-2365-2015Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.Class IITerminated
Z-2364-2015Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.Class IITerminated

Verification record

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