12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I Do
FDA 510(k)
FDA Class 2
·Dental
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
PRESSURIZED INFUSION PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code OWN·March 5, 2025
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·May 15, 2018
QUARTET
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTS·January 11, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
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