15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endophys Pressure Sensing Sheath Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107187·TRIAL 90-SRK-180620 POLY PS 6X20MM
MODIFICATION TO 3M TEGADERM CHG DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
LOCKING SCREW, FULLY THREADED 5X55 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 30, 2010
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code IKX·October 17, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020