Probe, Uptake, Nuclear
Regulation 892.1320
0510(k)s in 12 months (30 all time)
1recalls in 12 months (10 all time)
0recalls that name a 510(k)
Top companies in IZD
| Company | 510(k)s | Recalls |
|---|---|---|
| Mirion Technologies (Capintec), Inc. | 0 | 5 |
| Neoprobe Corp. | 5 | 0 |
| Capintec Inc | 0 | 4 |
| Care Wise Medical Products Corp. | 4 | 0 |
| Capintec Instruments, Inc. | 3 | 0 |
| Surgiceye GmbH | 3 | 0 |
| Medimatic | 2 | 0 |
| Nuclear Data, Inc. | 2 | 0 |
| Oakfield Instruments, Ltd. | 2 | 0 |
| Radiation Monitoring Devices, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 2014 | K133781 | DECLIPSESPECT LAPAROSCOPY Surgiceye GmbH, DE | IZD |
| Jan 25, 2013 | K123917 | DECLIPSESPECT VIEWER Surgiceye GmbH, DE | IZD |
| Mar 22, 2011 | K101887 | CONFIDENT SURGERY SUITE 300, MODEL CSS300 Surgiceye GmbH, DE | IZD |
| Feb 6, 2002 | K013751 | HANDHELD GAMMA FINDER (HGF) Silicon Instruments Gmhb, DE | IZD |
| Jul 2, 1999 | K983768 | MODIFICATION TO GAMMA GUIDANCE SYSTEM Radiation Monitoring Devices, Inc. | IZD |
| Aug 25, 1998 | K982442 | C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) Care Wise Medical Products Corp. | IZD |
| Jun 26, 1997 | K971167 | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES Neoprobe Corp. | IZD |
| Feb 10, 1997 | K961321 | GAMMA GUIDANCE SYSTEM Radiation Monitoring Devices, Inc. | IZD |
| Sep 13, 1996 | K962319 | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES Neoprobe Corp. | IZD |
| Feb 9, 1995 | K942580 | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES Neoprobe Corp. | IZD |
| Sep 7, 1993 | K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME Biodan Medical Systems, Ltd. | IZD |
| May 18, 1993 | K930962 | CAPTUS 2000 WEL COUNTER Capintec Instruments, Inc. | IZD |
| Dec 3, 1992 | K924586 | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE Capintec Instruments, Inc. | IZD |
| Oct 14, 1992 | K922117 | C-TRAK BIOPSY SYSTEM Care Wise Medical Products Corp. | IZD |
| Jun 10, 1992 | K915279 | NEOPROBE PORTABLE RADIOSCOPE DETECTOR Neoprobe Corp. | IZD |
| May 28, 1992 | K921428 | CAPTUS 500 Capintec Instruments, Inc. | IZD |
| Mar 30, 1992 | K920115 | MEDISCINT Oakfield Instruments, Ltd., GB | IZD |
| Sep 6, 1991 | K913055 | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 Atomic Products Corp. | IZD |
| Aug 28, 1990 | K902460 | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) Oakfield Instruments, Ltd., GB | IZD |
| Apr 19, 1990 | K896540 | ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE Nuclear Data Systems | IZD |
| Mar 14, 1990 | K896588 | ONCOPROBE II SYSTEM Care Wise Medical Products Corp. | IZD |
| Jun 6, 1989 | K891466 | ACCUSPEC THYROID UPTAKE SYSTEM Nuclear Data, Inc. | IZD |
| Jan 4, 1989 | K884770 | ONCOPROBE SYSTEM Care Wise Medical Products Corp. | IZD |
| Dec 29, 1986 | K864263 | NEOPROBE PORTABLE RADIOISOTOPE DETECTOR Neoprobe Corp. | IZD |
| Jun 5, 1984 | K841440 | ND62T THYROID UPTAKE SYSTEM Nuclear Data, Inc. | IZD |
| Dec 8, 1983 | K833140 | THYROID UPTAKE SYSTEM Advanced Medical Research Corp. | IZD |
| Feb 2, 1981 | K810006 | TOMOMATIC 64 Medimatic | IZD |
| Dec 4, 1978 | K781742 | INHAMATIC 33 Medimatic | IZD |
| Aug 4, 1977 | K771301 | DIGITAL RADIATION DETECTOR Actus, Inc. | IZD |
| Sep 17, 1976 | K760595 | CARDIAC PROBE G.D. Searle and Co. | IZD |
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