14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C50 and C80 Multi-parameter Patient Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
LEONE SPA
FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green
POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
FDA 510(k)
FDA Class 1
·General Hospital
EQUIA
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 12, 2015
DIGITAL RADIOGRAPHY CXDI
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·December 22, 2019
DIGITAL RADIOGRAPHY CXDI
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·December 22, 2019
DIGITAL RADIOGRAPHY CXDI
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·December 22, 2019
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 26, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 29, 2011
PRECISION 500D
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC.·Product code JAA·September 26, 2008
SUBDURAL ELECTRODE
FDA Adverse Event
Malfunction
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GYC·August 18, 2025
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020