27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
FDA 510(k)
FDA Class 2
·Immunology
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6913001574·CCAF Syringe Mix Stack Blue (9 gr) Blister
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0015741·CC/ Opaque Dentine OD-A4
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·09010782022849·CC/ Opaque Dentine OD-A4
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001574·artVeneer life upper anteriors, IXL, BL2
Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™
FDA UDI
SCANLAN INTERNATIONAL INC·00846159000825·Scanlan® VASCU-STATT® II Plus s-use bulldog cla...
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
FDA 510(k)
FDA Class 2
·Physical Medicine
COSMED QUARK
FDA 510(k)
FDA Class 2
·Anesthesiology
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·March 31, 2016
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·March 11, 2013
OMNIPOD INFUSION PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·July 1, 2014
INTEGRIS ALLURA 9 (BIPLANE)
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·January 26, 2011
PICC-NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004
Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code KKX·January 7, 2016
Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code FYA·October 8, 2014
Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016
Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015