11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045
FDA 510(k)
FDA Class 2
·Dental
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198864·AK3 Ultra Insert Trial Size 6, 16mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450279410·
CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR
FDA 510(k)
FDA Class 2
·Cardiovascular
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 19, 2024
ASR TAP SLV ADAP 12/14 -1
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 3, 2013
PROCEED* MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·September 16, 2014
UNIPLATE CERVICAL 18MM PLATE
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code KWQ·May 9, 2011
ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Radiometer America Inc·Product code CEM·January 12, 2011
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