8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
FDA 510(k)
FDA Class 1
·Microbiology
HARDYDISK CEFOTETAN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 9, 2014
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code LRK·October 19, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 18, 2007
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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