14 results · 27ms · Sources: EU EUDAMED, US FDA

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14HQ901G-B

FDA 510(k)
FDA Class 2 ·Radiology

Avex CX

FDA UDI
ULTRADENT PRODUCTS, INC.·00883205108111·Avex CX .018 LR3 D/HK (-6°T 3°A)

NA

FDA UDI
Synthes GmbH·10886982153548·4.5MM CORTEX SCREW 44MM

HAWKEYE™ Vertebral Body Replacement (VBR)

FDA UDI
Choice Spine, LP·00840996101035·VBR,SPACER,12X14X44,0 DEG

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551113881·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 M...

ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)

FDA 510(k)
FDA Class 1 ·Ophthalmic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

PUMP MMT-722WWL PRDGM INSULIN CL EN ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LZG·October 23, 2008

RSP SHOULDER

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code KWS·August 2, 2011

NATURALYTE

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 3, 2013

LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

FDA Adverse Event
Malfunction ·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

Alcon Custom Pak

FDA Enforcement
Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023