31 results · 23ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743618·LEVAMED ANKLE SUPPORT SAND IV

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743731·ACHIMED ACHILLES SUPP SAND IV

LiteTouch

FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730000725·LiteTouch Small Mask Assembly, Polybag

LEONE SPA

FDA UDI
LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450215258·

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 17, 2014

FINGER PULSE METER

FDA 510(k)
FDA Class 2 ·Cardiovascular

EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·November 23, 2016

AXIOS?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 10, 2025

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2016

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 13, 2016

AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 24, 2025

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·October 26, 2016

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 20, 2014

WALLFLEX BILIARY RX STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2023

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 9, 2018

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 2, 2013