17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TotalShield II Surgical Helmet System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sklar®
FDA UDI
SKLAR CORPORATION·10649111286308·WAUGH FCP CROSS SERR 1X2 12"
BD SYRINGE 10ML LL S/C 200
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 4, 2024
POLYBONE DENTAL
FDA 510(k)
FDA Class 2
·Dental
SOLCART B
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 14, 2022
STELLARIS OPTIMIZED STABILITY VAC PK 6/BX
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·October 8, 2014
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·August 6, 2019
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 4, 2011
BAERVELDT SHUNT
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code KYF·June 27, 2023
UNK - SCREWS: DHS/DCS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·April 15, 2021
GORE® CARDIOFORM ASD OCCLUDER
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MLV·June 25, 2024
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·October 11, 2023
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024