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

Miami Lakes, FL, US

DEMETECH CORP. appears in FDA device records in Miami Lakes, FL. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. 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
16
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Demetech Corp. between 2002 and 2020. The busiest year on record is 2003, with 2. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Demetech Corp., by decision year
YearClearances
20021
20032
20041
20052
20081
20101
20131
20142
20182
20192
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K201479DemeMASKFXXSubstantially Equivalent
K191361DemeDIOX Barbed Absorbable Surgical SutureNEWSubstantially Equivalent
K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureGATSubstantially Equivalent
K181578DemeTECH PTFE Nonabsorbable Surgical SutureNBYSubstantially Equivalent
K181582DemeTECH DemeDIOX absorbable surgical sutureNEWSubstantially Equivalent
K141007DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTUREGAQSubstantially Equivalent
K123940DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTUREGAMSubstantially Equivalent
K130083DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTUREGAMSubstantially Equivalent
K082097DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURENEWSubstantially Equivalent
K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTGALSubstantially Equivalent
K043330POLYPROPILENE SURGICAL SUTURESGAWSubstantially Equivalent
K043539DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLESGAMSubstantially Equivalent
K033550DXL CALSCANKGISubstantially Equivalent
K023030DEMETECH POLYESTER NONABSORBABLE SUTUREGATSubstantially Equivalent
K023028DEMETECH NYLON NONABSORBABLE SUTUREGARSubstantially Equivalent
K023029DEMETECH SILK NONABSORBABLE SUTUREGAPSubstantially Equivalent

Registered establishments

FDA registered establishments for Demetech Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10645843003063934DEMETECH CORP.5980 Miami Lakes Drive, Miami Lakes, FL 33014 US2026and 9 more, listed in full below

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