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

Dublin, OH, US

Neoprobe Corp. appears in FDA device records in Dublin, OH. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

FDA records hold 6 510(k) clearances for Neoprobe Corp. between 1986 and 2005. The busiest year on record is 1986, with 1. The most recent is 2005, with 1.

Clearances by year, as a table
510(k) clearance decisions for Neoprobe Corp., by decision year
YearClearances
19861
19921
19951
19961
19971
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K050088QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZERDPWSubstantially Equivalent
K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESIZDSubstantially Equivalent
K962319NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIESIZDSubstantially Equivalent
K942580NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESIZDSubstantially Equivalent
K915279NEOPROBE PORTABLE RADIOSCOPE DETECTORIZDSubstantially Equivalent
K864263NEOPROBE PORTABLE RADIOISOTOPE DETECTORIZDSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0701-05Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.Terminated
Z-0700-05Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system.The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.Terminated

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