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

Sanford, FL, US

CHRISTIE MEDICAL HOLDINGS, INC. appears in FDA device records in Sanford, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 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
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Christie Medical 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.

  • Christie Medical Holding Increcall

510(k) clearance history

FDA records hold 1 510(k) clearance for Christie Medical Holdings, Inc. in 2018.

Clearances by year, as a table
510(k) clearance decisions for Christie Medical Holdings, Inc., by decision year
YearClearances
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K171245Presygen/si-1MUDSubstantially Equivalent

Registered establishments

FDA registered establishments for Christie Medical Holdings, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30081619303008161930CHRISTIE MEDICAL HOLDINGS, INC.1201 Upsala Road, Sanford, FL 32771 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-1281-2012VeinViewer (R) by Luminetx, Model Number VV1.1 GS, Part No. P00800-L, Luminetx Corporation, Memphis, TN 38104 Product Usage: CTS Usage: Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skinInstrument may tip over if not moved correctly.Terminated
Z-1280-2012VeinViewer (R) by Luminetx, Model Number VV1.0, Part No: P00399-L, Luminetx Corporation, Memphis, TN 38104 Product Usage: Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skinInstrument may tip over if not moved correctly.Terminated

Verification record

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