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

Hudson, NC, US

Adhezion Biomedical, LLC appears in FDA device records in Hudson, NC. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 12 510(k) clearances for Adhezion Biomedical, LLC between 2008 and 2023. The busiest year on record is 2013, with 3. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Adhezion Biomedical, LLC, by decision year
YearClearances
20081
20091
20133
20143
20151
20161
20171
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223669SecurePortIV Advanced Catheter Securement AdhesiveNZPSubstantially Equivalent
K170505SecurePortIV Catheter Securement AdhesiveNZPSubstantially Equivalent
K161011SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin AdhesiveMPNSubstantially Equivalent
K150866SURGISEAL Topical Skin AdhesvieMPNSubstantially Equivalent
K133963SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVEMPNSubstantially Equivalent
K141215SURGISEAL TWIST TOPICAL SKIN ADHESIVEMPNSubstantially Equivalent
K140517SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVEMPNSubstantially Equivalent
K130329SURGISEAL TOPICAL SKIN ADHESIVEMPNSubstantially Equivalent
K130474SURGISEAL TOPICAL SKIN ADHESIVEMPNSubstantially Equivalent
K123936SURGISEAL TOPICAL SKIN ADHESIVEMPNSubstantially Equivalent
K083354FLORASEAL, MODEL FS350DNZPSubstantially Equivalent
K082993SURGISEAL TOPICAL SKIN ADHESIVEMPNSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

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

Verification record

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