13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ArcCHECK
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550162·GENUMEDI PT KNEE SUP SILVER L EW VII
Innnomed, Inc.
FDA UDI
INNOMED, INC.·00840277132987·Cheng Trephine 21mm
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
FDA 510(k)
FDA Class 2
·Radiology
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 10, 2019
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·March 12, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·September 26, 2014
ETS FLEX ARTICNG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 28, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 12, 2012
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 12, 2012
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 10, 2019
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, SINGLE ACTION, P/N 0250080584 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014