10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TDX N-ACETYLPROCAINAMIDE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Vivid MagnaSert IF-100 30K
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724B8302060·
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
APEX 90
FDA 510(k)
FDA Class 2
·Dental
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·May 12, 2014
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 13, 2012
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV.·Product code FNL·September 2, 2010
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022