18 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
FDA 510(k)
FDA Class 2
·Radiology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057370816·STRETCHER PAD 30" W X 3.5" H X 74" L SOFTCARE
GERATHERM BABYWATCH TEMPERATURE MONITOR
FDA 510(k)
FDA Class 2
·General Hospital
INTUITIVE SURGICAL ULTRASONIC SHEARS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 13, 2023
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
HAHN TAPERED IMPLANT 3.5 X 10 MM
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 6, 2023
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 26, 2013
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 24, 2008
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
LINEAR 7.5 FR. 40CC IAB
FDA Adverse Event
Injury
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 14, 2020
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 18, 2022
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 18, 2022
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 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