24 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131262356·H10, RITE 312 WL SGR
DreamWear Full
FDA UDI
Respironics, Inc.·00606959046221·Small Medium, DreamWear Full Face Mask, Large F...
NOYES IRIS SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896100077·NOYES IRIS SCISSORS SHARP/BLUNT BLADES FLAT HANDLE
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
STEALTHSTATION® S7´
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 29, 2013
PENTA LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 15, 2011
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·August 22, 2008
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013
Philips Respironics DreamWear Full Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013