23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXINIUM DH Fermoral Heads
FDA 510(k)
FDA Class 2
·Orthopedic
BD SYRINGE 3ML LL W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 22, 2025
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BD SYRINGE 3ML LL W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 22, 2025
BD SYRINGE 3ML LL W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 22, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 23, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 10, 2008
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 25, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 25, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 26, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 31, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 31, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 14, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 26, 2019
SOEHENDRA STENT RETRIEVER
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 26, 2017
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 23, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·August 27, 2019
Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017