14 results
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28ms
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Sources: EU EUDAMED, US FDA
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450211052·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450224427·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450201169·
TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
SELF ADHERING NAVIGUS GUIDE
FDA 510(k)
FDA Class 2
·Neurology
COMPRESSIBLE LIMB SLEEVE
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 2, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
DPM 6/7 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·September 16, 2014
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 20, 2011
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012