23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wet Original Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011602110·
IMAGEN Respiratory Syncytial Virus (RSV)
FDA UDI
OXOID LIMITED·05032384502950·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035927·2.0/2.4mm, Cannulated Countersink, Quick Release
Tungsten Carbide Burr
FDA UDI
ELLIQUENCE, LLC·00846338003906·
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023940·B-P MODULAR EXTENSION W/ULTRACOAT - 11 MM X 50 MM
MABIS
FDA UDI
D-M-S HOLDINGS, INC.·00767056160217·MATCH MATES SPHYG W/NYLON CUFF & NYLON CASE ROY...
WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
FDA 510(k)
FDA Class 1
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 30, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 3, 2022
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·September 18, 2018
OSSIX BONE, OSSIX PLUS
FDA Adverse Event
Injury
·DATUM DENTAL LTD.·Product code NPM·June 22, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 10, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·June 2, 2011
ALINITY I B12
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD·Product code CDD·July 15, 2020
BD MICROLANCE¿ NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 7, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2014
Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016