25 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
t:slim X2 5.0 Insulin Pump
FDA UDI
Tandem Diabetes Care, Inc.·00853052007271·t:slim X2 5.0 Insulin Pump, Replacement
Preclean Kit
FDA UDI
MEDIVATORS INC.·40677964007628·Preclean Plus Kit includes DEFENDO Air/Water Su...
Truliant
FDA UDI
Exactech, Inc.·10885862623713·Special Truliant DF FFG Uncaptured Anterior and...
FlowLogic Assert
FDA UDI
SONENDO, INC.·00810209421359·FlowLogic Assert Shaping File Variable Kit, 25mm
EliA Celiac Positive Control 2500/5000
FDA UDI
Phadia AB·07333066013176·EliA Celiac Positive Control 2500/5000
MFCD 118
FDA 510(k)
FDA Class 2
·Radiology
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
IM REAMER, AO FITTING BIXCUT 8,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·July 15, 2020
SCREWDRIVER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HXX·January 10, 2013
OPTIPAC-S 40 REFOBACIN BONE CEMENT R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 28, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 24, 2011
ARCHITECT C8000
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·February 21, 2008
CUSTOM JIG FOR CONSTRAINED SHOULDER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LXH·December 18, 2012
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MHX·September 19, 2025
IH-1000 AUTOMATED ANALYZER SYSTEM
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·August 26, 2025
TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·February 8, 2019
TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·February 8, 2019
CER OPTION TYPE 1 TPR SLEVE -6
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·February 19, 2020