14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
EMIT VALPROIC ACID ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117521·Graefe Iris Forceps, 1x2 Teeth, Curved
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209125791·
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEODENT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 6, 2020
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·January 3, 2023
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYE·May 8, 2014
UNKNOWN REJUVENATE HIP DEVICE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 17, 2012
CLEAR CARE LENS CARE SOLUTION
FDA Adverse Event
Injury
·CIBA VISION STERILE MANUFACTURING·Product code LPN·August 11, 2010
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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
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