13 results
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26ms
·
Sources: EU EUDAMED, US FDA
ACCU-PREP PROGRAMMABLE AUTO-DILUTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
1077 EARTIP 9-13 FOAM 250 PCS
FDA UDI
PATH medical GmbH·04260223141294·
INSTINCT ENDOSCOPIC HEMOCLIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOSPITAL SPACER
FDA 510(k)
FDA Class 2
·Anesthesiology
KARL STORZ
FDA Adverse Event
Injury
·KARL STORZ ENDOSCOPY·Product code KQT·January 21, 2004
PLUM A+ DRIVER NEW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 17, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 13, 2010
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PKL·July 19, 2021
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2022
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014