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

Salisbury, MA, US

ANDOVER HEALTHCARE, INC. appears in FDA device records in Salisbury, MA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 7 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
7
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Andover Healthcare Inc. in 2009.

Clearances by year, as a table
510(k) clearance decisions for Andover Healthcare Inc., by decision year
YearClearances
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K083133SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGSFROSubstantially Equivalent

Registered establishments

FDA registered establishments for Andover Healthcare Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12207991220799ANDOVER HEALTHCARE, INC.9 Fanaras Dr, SALISBURY, MA 01952 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-1828-2024Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)A packaging seal gap could impact the sterility of the product.Class IIOpen, Classified
Z-0184-2020Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrapIncomplete packaging seal of sterile productClass IITerminated
Z-0183-2020Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrapIncomplete packaging seal of sterile productClass IITerminated
Z-0182-2020Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrapIncomplete packaging seal of sterile productClass IITerminated
Z-0181-2020Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrapIncomplete packaging seal of sterile productClass IITerminated
Z-0180-2020Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrapIncomplete packaging seal of sterile productClass IITerminated
Z-0179-2020Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.Incomplete packaging seal of sterile productClass IITerminated

Verification record

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