25 results · 24ms · Sources: EU EUDAMED, 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