19 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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Disposable Endoscope Valves Set A
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE
STILLE Osteotomes
FDA UDI
Stille AB·07332339211509·OSTEOTOME CINELLI STILLE double-guarded 14 mm 1...
MaxFuse,VBR, 12 (D) x 14 (W) x 13 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055882·VBR, 12 (D) x 14 (W) x 13 (H)
TOTAL BILE ACIDS ASSAY, MODEL DZ042A
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
FDA 510(k)
FDA Class 2
·Dental
PASSEO-18 5/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 6/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 26, 2024
PASSEO-18 2.5/170/130
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 8, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019