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Neoprobe Corp.

United StatesFDA applicant, unverified

Devices
6
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Neoprobe Corp. makes

Neoprobe Corp. manufactures portable radioscopes and radioisotope detectors, including standalone units and models with accessory kits. Their products are designed for detecting radioactive materials and monitoring blood flow, such as the QUANTIX/OR blood flow monitor with optional vessel stabilizers. These devices are intended for use in medical, industrial, and environmental settings where radiation detection or perfusion assessment is required.

The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with several models authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue6

Newest first, rows 1-6 of 6

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Neoprobe Corp., initiated on 2004-12-13. By recorded status: 2 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2004

    • 13 Dec 2004 Z-0700-05 Unclassified (pre-2012) Terminated 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. Distribution: Domestic accounts: Boston University Medical Center, 88 E. Newton St., B-402, Boston, MA 02118; Criticor, 2943 Pullman…
      Full distribution text Domestic accounts: Boston University Medical Center, 88 E. Newton St., B-402, Boston, MA 02118; Criticor, 2943 Pullman St., Santa Ana, CA 92705; Ilex Medical, 370 Cypress Creek Circle, Olsmar, FL 34677; Peerless Medical Corp., 705 Summer Oak Dr., Ellisville, MO 63021; Rolomac International, 1836 NE 213 Ln., Miami FL, 33179; University of Miami, PO Box 01690 (R-114), Miami, FL 33101. Foreign accounts: Asia Health Care Co Ltc., 4 FL-3, No 601, Chung Cheng Rd., Taipei, Taiwan, R.O.C.; Century Medical Inc., 1-6-4 Osaki, Shinagawa-KU, Tokyo, Japan 141-8588; Farmplex Cardic, Sheldare Enterprises, Ltd., 20-22 Bedford Row, London, United Kingdom; Integmed Ltd., 51 Hung To Road Kwun Tong, Kowloon, Hong Kong; Reysas Medical Corp., Hulya Sokal No. 21 GOP, 06700 Ankara, Turkey; Rahn AG, Dorflistrasse 12, CH-8050, Zurici, Switzerland.
      Submission number: K030357
    • 13 Dec 2004 Z-0701-05 Unclassified (pre-2012) Terminated 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. Distribution: Domestic accounts: Boston University Medical Center, 88 E. Newton St., B-402, Boston, MA 02118; Criticor, 2943 Pullman…
      Full distribution text Domestic accounts: Boston University Medical Center, 88 E. Newton St., B-402, Boston, MA 02118; Criticor, 2943 Pullman St., Santa Ana, CA 92705; Ilex Medical, 370 Cypress Creek Circle, Olsmar, FL 34677; Peerless Medical Corp., 705 Summer Oak Dr., Ellisville, MO 63021; Rolomac International, 1836 NE 213 Ln., Miami FL, 33179; University of Miami, PO Box 01690 (R-114), Miami, FL 33101. Foreign accounts: Asia Health Care Co Ltc., 4 FL-3, No 601, Chung Cheng Rd., Taipei, Taiwan, R.O.C.; Century Medical Inc., 1-6-4 Osaki, Shinagawa-KU, Tokyo, Japan 141-8588; Farmplex Cardic, Sheldare Enterprises, Ltd., 20-22 Bedford Row, London, United Kingdom; Integmed Ltd., 51 Hung To Road Kwun Tong, Kowloon, Hong Kong; Reysas Medical Corp., Hulya Sokal No. 21 GOP, 06700 Ankara, Turkey; Rahn AG, Dorflistrasse 12, CH-8050, Zurici, Switzerland.
      Submission number: K030357

Frequently asked questions

How many devices does Neoprobe Corp. have in the registry?

The registry currently lists 6 devices for Neoprobe Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Neoprobe Corp.'s devices?

Among its 6 most recently registered devices, Neoprobe Corp. has devices listed in FDA 510(k) (6 devices).

What risk classes do Neoprobe Corp.'s devices fall under?

Among its 6 most recently registered devices, the classes recorded for Neoprobe Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Neoprobe Corp.?

FDA recall records list 2 recalls initiated by Neoprobe Corp., the most recent initiated on 13 Dec 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Neoprobe Corp. in the registry?

The most recently registered devices listed for Neoprobe Corp. include NEOPROBE PORTABLE RADIOSCOPE DETECTOR, NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES, NEOPROBE PORTABLE RADIOISOTOPE DETECTOR and NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES.

Generated automatically from registry data and not verified by a human reviewer.