DXO

Death

10

Injury

156

Malfunction

884

Total

1,050

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K251367 — OptoMonitor 3 Opsens, Inc. · 2026-01-16
• K241418 — OptoMonitor 3 Opsens, Inc. · 2025-02-12
• K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ Acist Medical Systems, Inc. · 2024-07-17
• K222216 — TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC · 2022-12-22
• K202943 — OptoMonitor 3 Opsens, Inc. · 2020-11-24
• K193620 — OptoMonitor 3 Opsens, Inc. · 2020-06-18
• K193279 — Comet II Pressure Guidewire Boston Scientific Corporation · 2019-12-23
• K192340 — OptoMonitor Opsens, Inc. · 2019-12-12
• K190852 — Zurich Pressure Guidewire System Model 100 Zurich Medical, Inc. · 2019-08-14
• K183413 — TruWave Disposable Pressure Transducer Edwards Lifeciences, LLC · 2019-05-01
• K180558 — PressureWire X St. Jude Medical (Now Part of Abbott Medical) · 2018-03-28
• K171996 — TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC · 2017-10-23
• K163376 — Mikro-Cath Pressure Catheter Millar, Inc. · 2017-03-10
• K161263 — OptoMonitor II Opsens, Inc. · 2016-09-13
• K161171 — PressureWire X Guidewire St. Jude Medical, Inc. · 2016-08-15
• K151610 — Comet Pressure Guidewire Boston Scientific Corporation · 2015-10-06
• K142749 — TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC · 2015-01-18
• K140466 — PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 St. Jude Medical Systems AB · 2014-11-13
• K141495 — TRUWAVE DISPOSABLE PRESSURE TRANSDUCER Edwards Lifesciences, LLC · 2014-09-03
• K132474 — CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER Acist Medical Systems · 2014-01-30
• K131452 — PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 St. Jude Medical Systems AB · 2013-09-05
• K113584 — PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER St Jude Medical · 2012-03-02
• K112323 — CARDIA-CATH Millar Instruments, Inc. · 2011-10-18
• K093111 — MIKRO-CATH, MODEL 825-0101 Millar Instruments, Inc. · 2010-01-05
• K080813 — PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER Radi Medical Systems AB · 2008-07-01
• K070487 — SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX Volcano Corporation · 2007-03-16
• K062769 — PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 Radi Medical Systems AB · 2006-12-04
• K053016 — WIRELESS PHYSIOLOGIC MONITORING SYSTEM Edwards Lifesciences, LLC · 2005-12-30
• K031662 — PRESSURE WIRE SENSOR, MODELS 12004/12304 Radi Medical Systems AB · 2003-06-06
• K022187 — PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 Radi Medical Systems AB · 2002-09-24
• K935166 — FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER Millar Instruments, Inc. · 1994-08-05
• K941283 — INNERSENSE DISPOSABLE MICROTRANSDUCER Becton Dickinson Vascular Access, Inc. · 1994-04-19
• K925638 — PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 Baxter Healthcare Corp · 1993-10-18
• K924737 — INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER Becton Dickinson Vascular Access, Inc. · 1993-08-23
• K920580 — TRANSDUCER, PRESSURE, CATHETER TIP Medamicus, Inc. · 1993-01-07
• K913042 — MODIFICATIONS TO SERIES OF CARDIAC CATHETERS Sentron, Inc. · 1992-10-21
• K915775 — MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN Millar Instruments, Inc. · 1992-04-20
• K910429 — SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER Baxter Healthcare Corp · 1991-07-11
• K895721 — MILLAR MIKRO-TIP PULSE TRANSDUCER Millar Instruments, Inc. · 1989-12-07
• K894033 — DISPOSABLE CATHETER PRESSURE TRANSDUCER Deseret Medical, Inc. · 1989-10-17
• K894286 — PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER Ppg Industries, Inc. · 1989-10-12
• K894747 — PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. Endosonics Corp. · 1989-10-12
• K890492 — PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. Endosonics Corp. · 1989-03-02
• K883202 — ULTRASONIC IMAGING CATHETER Boston Scientific Corp · 1988-11-23
• K883436 — PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER Ppg Industries, Inc. · 1988-10-17
• K880830 — SENTORR ARTERIAL PRESSURE SENSOR Ohmeda Medical · 1988-08-12
• K882031 — VITALERT 2000 VITAL SIGNS MONITOR Draeger Medical, Inc. · 1988-07-28
• K874165 — DISPOSABLE CATHETER PRESSURE TRANSDUCER Deseret Medical, Inc. · 1988-06-09
• K872291 — ESCORT PORTABLE PATIENT MONITOR Medical Data Electronics · 1987-09-25
• K863969 — CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D Camino Laboratories, Inc. · 1987-05-27
• K864000 — FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 Fiberoptic Sensor Technlogies, Inc. · 1987-01-16
• K860526 — NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH Nova Medical Specialties · 1986-05-02
• K843969 — MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER Gould, Inc. · 1985-01-23
• K842150 — TRANSDUCER-MONITOR INTERFACING Millar Instruments, Inc. · 1984-10-26
• K842213 — VSM R1 Physio-Control Corp. · 1984-10-26
• K842005 — MODEL 110-5 & 140-8 Camino Laboratories, Inc. · 1984-08-03
• K834040 — MINATURE PRESSURE TRANSDUCER Carbomedics, Inc. · 1984-02-10
• K832384 — BP TRANSDUCER HOLDERS TH-2,3 & 4 American Bentley · 1983-11-14
• K832579 — PHYSIOLOGICAL PRESS. MEASUREMENT CATH Camino Laboratories, Inc. · 1983-10-20
• K832604 — PHYSIOLOGICAL PRESSURE MEASUREMENT CATH Camino Laboratories, Inc. · 1983-10-20
• K830638 — PHYSIOLOGICAL PRESSURE MEASUREMENT SYS Camino Laboratories, Inc. · 1983-04-18
• K801756 — MMI/GAELTEC CATHETER TIP TRANSDUC Medical Measurements, Inc. · 1980-08-20
• K792177 — MILLAR MIKRO-TIP CATHETER TRANSDUCER Millar Instruments, Inc. · 1979-11-15
• K790036 — DIGITAL BPM Narco Air-Shields · 1979-03-02