10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
FDA 510(k)
FDA Class 2
·Hematology
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 5, 2025
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 2, 2013
OPTI-FREE REPLENISH
FDA Adverse Event
Injury
·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·March 23, 2011
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·April 18, 2008
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016