18 results
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28ms
·
Sources: EU EUDAMED, US FDA
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306801761·DeBakey Tissue Forceps, 1.5 mm, 16 cm / 6.5 in
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0600100·Tray Insert, Trials
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0600100·Tray Insert, ISP Instrument Prep
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0600100·Tray Insert, Lumbar Instruments, 2
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345027237·Inserter, 7-10MM, Lumbar Straight
ROUND FILTERS W/INDICATOR
FDA Adverse Event
Malfunction
·SPS MEDICAL·Product code FRG·February 28, 2014
TRULINK
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522102134·LW SET,SNP,DIN,TEL,64CM/ 25.2IN,AAMI,5LW/ST,1/ST
ART-M1, MODEL M1-1-ART-A1
FDA 510(k)
FDA Class 2
·Dental
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Widex
FDA UDI
Widex A/S·05706069678901·Widex EVOKE E-CIC-M (Clay brown ) 110
Widex
FDA UDI
Widex A/S·05706069678895·Widex EVOKE E-CIC-M (Light beige ) 110
Widex
FDA UDI
Widex A/S·05706069678918·Widex EVOKE E-CIC-M (Dark brown ) 110
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2013
UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·April 18, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 11, 2008
BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·November 21, 2024
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024