System, Rebreathing, Radionuclide
Regulation 892.1390
1510(k)s in 12 months (49 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in IYT
| Company | 510(k)s | Recalls |
|---|---|---|
| Medipart Jerry Alexander | 23 | 0 |
| Amici, Inc. | 5 | 0 |
| Medi Nuclear Corp., Inc. | 3 | 0 |
| Mallinckrodt Critical Care | 2 | 0 |
| Vital Signs, Inc. | 2 | 0 |
| Atomic Products Corp. | 1 | 0 |
| Cadema Medical Products, Inc. | 1 | 0 |
| Cis-Us, Inc. | 1 | 0 |
| Cyclomedica Australia Pty, Ltd. | 1 | 0 |
| Diagnostic Isotapes, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 2026 | K253942 | Pulmonex II Xenon System (132-503) Mirion Technologies (Capintec), Inc. | IYT |
| Sep 1, 2020 | K200916 | Patient Administration Set Cyclomedica Australia Pty, Ltd., AU | IYT |
| Nov 3, 1995 | K953513 | XENON CIRCUIT King Systems Corp. | IYT |
| Aug 11, 1995 | K952223 | XENON GAS BREATHING CIRCUIT Intertech Resources, Inc. | IYT |
| Feb 27, 1992 | K914747 | XENON CIRCUIT Gibeck, Inc. | IYT |
| Oct 28, 1991 | K913416 | TETLEY PATIENT ADMINISTRATION SET Tetley Medical , Ltd. | IYT |
| Aug 2, 1991 | K912626 | BOLUS XENON CIRCUIT Vital Signs, Inc. | IYT |
| Jan 14, 1991 | K904684 | AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION Amici, Inc. | IYT |
| Jan 14, 1991 | K903805 | AMICI XENON ADMINISTRATION SET Amici, Inc. | IYT |
| Oct 3, 1990 | K903694 | AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE Amici, Inc. | IYT |
| Feb 26, 1990 | K896885 | DISPOSABLE RESPIRTORY KIT (MP-200) Medipart Jerry Alexander | IYT |
| Feb 1, 1990 | K896125 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M Medipart Jerry Alexander | IYT |
| Jan 22, 1990 | K896476 | DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD Medipart Jerry Alexander | IYT |
| Jan 22, 1990 | K896475 | DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD Medipart Jerry Alexander | IYT |
| Jan 22, 1990 | K896124 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 Medipart Jerry Alexander | IYT |
| Jul 18, 1988 | K881812 | AERO-MIST NEBULIZER Cadema Medical Products, Inc. | IYT |
| Apr 11, 1988 | K871868 | VENTI-SCAN II Atomic Products Corp. | IYT |
| Feb 12, 1988 | K872920 | AMICI KRYPTON ADMINISTRATION SYSTEM* Amici, Inc. | IYT |
| Oct 20, 1987 | K865107 | AERO-VENT AEROSOL UNIT Medi Nuclear Corp., Inc. | IYT |
| Mar 3, 1987 | K865084 | AMICI XENON REBREATHING SYSTEM* Amici, Inc. | IYT |
| Nov 4, 1986 | K863996 | MODEL XE-103 XENON/MASTER II Medi Nuclear Corp., Inc. | IYT |
| Oct 27, 1986 | K863778 | VENTICIS II Cis-Us, Inc. | IYT |
| Aug 1, 1986 | K862795 | MP-070-M RADIOAEROSOL KIT Medipart Jerry Alexander | IYT |
| Aug 1, 1986 | K862794 | MP-070 RADIOAEROSOL KIT Medipart Jerry Alexander | IYT |
| Aug 1, 1986 | K862793 | MP-066-M RADIOAEROSOL KIT Medipart Jerry Alexander | IYT |
| Aug 1, 1986 | K862792 | MP-066 RADIOAEROSOL KIT Medipart Jerry Alexander | IYT |
| Aug 1, 1986 | K862791 | MP-30XM-IE FACE MASK AND FILTER KIT Medipart Jerry Alexander | IYT |
| Nov 7, 1985 | K853579 | MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133 Medipart Jerry Alexander | IYT |
| Nov 7, 1985 | K853576 | MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M Medipart Jerry Alexander | IYT |
| Nov 7, 1985 | K853570 | MEDIPART DRIERITE MP-1002 Medipart Jerry Alexander | IYT |
| Sep 10, 1985 | K851201 | MEDIPART LUND AEROSOL KIT MP-1024A-M Medipart Jerry Alexander | IYT |
| Sep 10, 1985 | K851200 | MEDIPART LUNG AEROSOL KIT MP-1024A Medipart Jerry Alexander | IYT |
| Sep 10, 1985 | K851199 | MEDIPART LUNG AEROSOL KIT MP-1012A-M Medipart Jerry Alexander | IYT |
| Sep 10, 1985 | K851198 | MEDIPART LUNG AEROSOL KIT MP-1012A Medipart Jerry Alexander | IYT |
| Aug 19, 1985 | K850837 | MEDIPART FACE MASK & FILTER MP-30XM-I Medipart Jerry Alexander | IYT |
| Aug 19, 1985 | K850836 | MEDIPART FACE MASK MP-XM-I Medipart Jerry Alexander | IYT |
| Aug 7, 1985 | K853056 | RESPIR GARD-II FACE MASK CORRUGATED TUBING Marquest Medical Products, Inc. | IYT |
| Jul 24, 1985 | K852693 | XEN-REX I Nuclear Pharmacy, Inc. | IYT |
| Apr 30, 1985 | K850367 | MEDIPART XENON BREATHING KIT MP-02XM-I Medipart Jerry Alexander | IYT |
| Apr 30, 1985 | K850366 | MEDIPART XENON BREATHING KIT MP-OIXM-I Medipart Jerry Alexander | IYT |
| Jan 14, 1985 | K843640 | XENON XE 127/XE 133 GAS DISPENSER Mallinckrodt Critical Care | IYT |
| Dec 24, 1984 | K844496 | MEDIPART XENON BREATHING KIT MP-01XM Medipart Jerry Alexander | IYT |
| Dec 17, 1984 | K844495 | MEDIPART XENON BREATHING KIT MP-02XM Medipart Jerry Alexander | IYT |
| Mar 31, 1982 | K820571 | XENAMATIC SERIES OF XENON REBREATH DEV Diversified P.A. | IYT |
| Mar 2, 1982 | K820143 | XENON DELIVERY SYSTEM Vital Signs, Inc. | IYT |
| Jun 2, 1981 | K811118 | KRYPTON MASKS & TUBING Medi-Physics Inc. Dba Nycomed Amersham Imaging | IYT |
| Apr 14, 1981 | K810819 | MEDI/NUCLEAR #XE-102 XENON/MASTER Medi Nuclear Corp., Inc. | IYT |
| Dec 4, 1978 | K781933 | DISPENSOR, XENON GAS Diagnostic Isotapes, Inc. | IYT |
| Jul 17, 1978 | K781107 | DISPENSER, GAS XENON Mallinckrodt Critical Care | IYT |
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