16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ROLLO 215X50X19E/QT-HS80/ELI200 MN
FDA UDI
AB MEDICA GROUP, S.A.·08428763005766·
PAQ.215X280X200/QT80/BURD7868
FDA UDI
AB MEDICA GROUP, S.A.·08428763010517·
TIGER Spine System
FDA UDI
CORELINK LLC·M72560215010·5500 SERIES CONNECTOR RIGHT OFFSET RETAINING WA...
TIGER Spine System
FDA UDI
CORELINK LLC·M7256021501·5500 SERIES CONNECTOR - RIGHT OFFSET - RETAINI...
SYRINGE 60CC LL TIP CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·June 14, 2019
ENDOPOUCH RETRIEVER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
H.M.T. ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
BARD FLAT MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·March 8, 2013
EYE SURGERY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·February 16, 2011
AFFINITY 3
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·March 26, 2008
BD LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·June 21, 2019
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
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
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014