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

Vierpolders Zuid-Holland, NL

VITREQ BV appears in FDA device records in Vierpolders Zuid-Holland, NL. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
16
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Vitreq BV between 2019 and 2020. The busiest year on record is 2019, with 1. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vitreq BV, by decision year
YearClearances
20191
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K202038CryoTreQHPSSubstantially Equivalent
K182646Vitreq disposable laser probes, light fibers and ChandelierHQBSubstantially Equivalent

Registered establishments

FDA registered establishments for Vitreq BV, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30120374253012037425VITREQ BVSeggelant-Noord 2, Vierpolders Zuid-Holland 3237 MG NL2026and 1 more, listed in full below

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-0861-2020VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0860-2020VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0859-2020VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0858-2020VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0857-2020VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0856-2020VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0855-2020VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0854-2020VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0853-2020VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0852-2020VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0851-2020VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0850-2020VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0849-2020VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0848-2020(1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0847-2020(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated
Z-0846-2020(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140Microscopic tears of the sterile pouch may compromise sterilityClass IITerminated

Verification record

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