22 results
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27ms
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Sources: EU EUDAMED, US FDA
DELTA 16 TACT
FDA 510(k)
FDA Class 2
·Radiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496001171·MAGIC 50, SIZE ML, FUMO, TIGHTS WITH A THREE-DI...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001171·artVeneer life upper anteriors, BS, B1
CALLCORD,6FT,COOL GRAY 6C,1/4",UL,ASCOM
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828100076·CALLCORD,6FT,COOL GRAY 6C,1/4",UL,ASCOM
Silicone Tubing
FDA UDI
INVOTEC INTERNATIONAL, INC.·00818501023004·Silicone Tubing 0.062" X 0.125"
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450156568·
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
FDA 510(k)
FDA Class 2
·Neurology
CBYON SURGICAL OPERATING SYSTEM (SOS)
FDA 510(k)
FDA Class 2
·Neurology
AUTOPULSE® LIFEBAND
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·February 17, 2023
INDIGO SYSTEM CAT RX ASPIRATION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code QEX·March 29, 2024
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS GMBH·Product code NBW·March 13, 2013
SYNCHRON LX® I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·February 24, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 22, 2008
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·October 31, 2025
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·November 4, 2015
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013