25 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
FDA 510(k)
FDA Class 2
·Microbiology
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003401·MCK PATELLOFEMORAL TRIAL (3 RIGHT)
Denovo Preformed Matrix Band
FDA UDI
Denovo Dental, Inc.·00810059291096·Denovo Preformed Matrix Band - Adult 1/4, Size 13
TEMP IT
FDA 510(k)
FDA Class 2
·Dental
ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028
FDA 510(k)
FDA Class 2
·Dental
PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code GEA·August 31, 2021
INSERTION HANDLE FOR SUPRAPATELLAR
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·August 26, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026
IOLMASTER 500
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·February 10, 2017
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 14, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 20, 2011
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code HAW·May 24, 2013
IOLMASTER 500
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·February 10, 2017
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026
IOLMASTER 500
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·May 25, 2017
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
PROTECTION SLEEVE F/INSERTION INSTR
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code GEA·December 13, 2018
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025
TERUMO RADIFOCUS GUIDE WIRE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025