39 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
FDA 510(k)
FDA Class 2
·General Hospital
Bur PM2-70 80K Diamond coarse Ø4.5 sterile
FDA UDI
Bien-Air Surgery SA·17630055514124·
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964066207·Endo Carry-On Procedure Kit
UniHeart™ Lo-Flo Continuous Nebulizer,Ped.Super Spike Mask
FDA UDI
WESTMED, INC.·00709078000317·UniHeart™ Lo-Flo Continuous Nebulizer,Ped.Super...
UniHEART™
FDA UDI
SUNMED, LLC·10889483227558·UniHEART™ Low Flow Continuous Nebulizer, Super ...
AIM™FEMORAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868003134·
Copper Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989027518·COPPER NITI 40 BAF16X22UP SM PK10
DEBAKEY NEWMAN DOUBLE ARTICULATING TUNGSTEN CARBIDE NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921009420·DEBAKEY NEWMAN DOUBLE ARTICULATING TUNGSTEN CAR...
DEBAKEY NEWMAN DOUBLE ARTICULATING TUNGSTEN CARBIDE NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059115·DEBAKEY NEWMAN DOUBLE ARTICULATING TUNGSTEN CAR...
BETA TITANIUM ARCHWIRE
FDA UDI
Ortho Organizers, Inc.·00190707067113·.018 Upper Pro Form™ Beta Titanium Archwires
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450159019·
U04
FDA 510(k)
FDA Class 2
·Radiology
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 27, 2026
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 19, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 19, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011