Panels › Cardiovascular › Product code DRY · Class 2
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Regulation 870.4330
0510(k)s in 12 months (47 all time)
0recalls in 12 months (40 all time)
37recalls that name a 510(k)
Top companies in DRY
| Company | 510(k)s | Recalls |
|---|---|---|
| Terumo Cardiovascular Systems Corp. | 4 | 38 |
| Spectrum Medical , Ltd. | 7 | 0 |
| 3M Company | 3 | 0 |
| 3M Healthcare | 2 | 0 |
| Cardiovascular Devices, Inc. | 2 | 0 |
| International Biophysics Corp. | 2 | 0 |
| Spectrum Medical, Llp | 2 | 0 |
| 3M Health Care, Ltd. | 1 | 0 |
| American Bentley | 1 | 0 |
| Bentley Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2024 | K234065 | CDI OneView Monitoring System Terumo Cardiovascular Systems Corporation | DRY |
| Apr 1, 2021 | K202154 | B-Capta Livanova Deutschland, GmbH, DE | DRY |
| Oct 2, 2020 | K202557 | Quantum Workstation 12 Elite Spectrum Medical , Ltd., GB | DRY |
| Nov 2, 2018 | K182110 | CDI Blood Parameter Monitoring System 550 Terumo Cardiovascular Systems Corporation | DRY |
| Aug 17, 2018 | K181923 | Quantum Workstation 12.1 Spectrum Medical , Ltd., GB | DRY |
| Mar 28, 2018 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas Spectrum Medical , Ltd., GB | DRY |
| Jan 18, 2017 | K163657 | Quantum Workstation Spectrum Medical , Ltd., GB | DRY |
| Oct 23, 2014 | K133157 | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 Medtronic, Inc. | DRY |
| Jul 25, 2014 | K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 Terumo Cardiovascular Systems Corp. | DRY |
| Nov 20, 2012 | K123039 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 Terumo Cardiovascular Systems Corp. | DRY |
| May 31, 2011 | K110957 | M4 MONITOR Spectrum Medical, Llp, GB | DRY |
| Jan 6, 2011 | K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) Sorin Group Deutschland GmbH | DRY |
| Jul 10, 2009 | K091908 | M3 MONITOR Spectrum Medical , Ltd., GB | DRY |
| Apr 22, 2009 | K090147 | BLOOD MONITORING UNIT, MODEL BMU 40 Maquet Cardiopulmonary, AG, DE | DRY |
| Aug 17, 2007 | K072131 | M3 MONITOR Spectrum Medical , Ltd., GB | DRY |
| Jul 11, 2007 | K071725 | M2 MONITOR Spectrum Medical , Ltd., GB | DRY |
| Sep 13, 2006 | K062468 | SPECTRUM M2 MONITOR Spectrum Medical, Llp, GB | DRY |
| Sep 14, 2001 | K012743 | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T Medtronic Perfusion Systems | DRY |
| Jul 28, 2000 | K001388 | DATA MASTER PERFUSION MONITORING SYSTEM Dideco | DRY |
| May 15, 1998 | K980732 | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT 3M Healthcare | DRY |
| Dec 8, 1997 | K973472 | 3M CDI H/S CUVETTES WITH HEPARON TREATMENT 3M Healthcare | DRY |
| Nov 6, 1997 | K972962 | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 3M Company | DRY |
| May 14, 1996 | K955380 | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) International Biophysics Corp. | DRY |
| May 14, 1996 | K955379 | IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) International Biophysics Corp. | DRY |
| Feb 17, 1995 | K941922 | MEDSAT OXYGEN SATURATION SYSTEM Medtronic Bio-Medicus, Inc. | DRY |
| Nov 10, 1993 | K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO 3M Health Care, Ltd. | DRY |
| Jan 15, 1992 | K915265 | CDI(TM) H/S CUVETTE, MODIFICATION 3M Company | DRY |
| Jan 15, 1992 | K915255 | CDI(TM) 300, 400 & 100, MODIFICATION 3M Company | DRY |
| Oct 15, 1991 | K910421 | SATURATION/HEMATOCRIT MONITOR SYSTEM Medtronic Vascular | DRY |
| Sep 14, 1990 | K903729 | GOLD GATORS Lead-Lok, Inc. | DRY |
| Jul 31, 1990 | K900682 | PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE Contour Electrodes, Inc. | DRY |
| Jul 31, 1990 | K900459 | APPLICARD (EKG) Medi-Globe Corp. | DRY |
| May 24, 1988 | K881006 | STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 Shiley, Inc. | DRY |
| May 13, 1988 | K874839 | STAT-SAT Gish Biomedical, Inc. | DRY |
| Jun 18, 1987 | K871686 | GEM-CRIT CHECK Diamond Sensor Systems | DRY |
| Jun 5, 1987 | K871221 | CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 Cardiovascular Devices, Inc. | DRY |
| Aug 25, 1986 | K862953 | CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE Classic Medical Products, Inc. | DRY |
| Jul 18, 1986 | K862069 | CARDIOMET 4000 GAS MONITORING SYSTEMS Biomedical Sensors, Inc., GB | DRY |
| Jun 2, 1986 | K861277 | CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 Critichem, Inc. | DRY |
| Jan 8, 1986 | K854357 | GEM-6, WITH COMPONENTS Diamond Electro-Tech, Inc. | DRY |
| Sep 16, 1985 | K852124 | HEMATOCRIT-SATURATION MONITOR HSM-100 American Bentley | DRY |
| Oct 24, 1984 | K843709 | COBE SATURATION CELL Cobe Laboratories, Inc. | DRY |
| Oct 18, 1984 | K843538 | PO 2 LYTRODE Polystan C/O Vitalcor, Inc. | DRY |
| May 27, 1983 | K831225 | GAS-STAT MONITORING SYSTEM Cardiovascular Devices, Inc. | DRY |
| Jan 5, 1983 | K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 Bentley Laboratories, Inc. | DRY |
| May 25, 1982 | K821159 | IN-LINE OXYGEN MONITORING SYSTEM G.D. Searle and Co. | DRY |
| Jul 20, 1981 | K811391 | OXIMETRIX ACCU SAT CPB Oximetrix, Inc. | DRY |
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