10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CRT DISPLAY #1310B
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RENAX A.V. FISTULA NEEDLE SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OXF ANATOMIC BEARING RT SM SIZE 6
FDA Adverse Event
Injury
·BIOMET LTD·Product code NRA·May 9, 2014
LOCKSCR Ø5 L40 F/NAILS TAN LIGHT GREEN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·October 24, 2012
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·August 17, 2010
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024