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

Doral, FL, US

BioTissue Holdings Inc. appears in FDA device records in Doral, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. 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
1
PMA records
0
Recall records
3
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to BioTissue Holdings 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.

  • TissueTech, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for BioTissue Holdings Inc. in 2026.

Clearances by year, as a table
510(k) clearance decisions for BioTissue Holdings Inc., by decision year
YearClearances
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253204CatalyzeKGNSubstantially Equivalent

Registered establishments

FDA registered establishments for BioTissue Holdings Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30048027403009809074BioTissue Holdings Inc.8305 Nw 27th St, Suite 101, Doral, FL 33122 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-0552-2021PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.Potential exposure of product to microbial contamination.Class IITerminated
Z-0551-2021PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.Potential exposure of product to microbial contamination.Class IITerminated
Z-0550-2021PROKERA, non-sterile - Product Usage: Biologic corneal bandage.Potential exposure of product to microbial contamination.Class IITerminated

Verification record

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