17 results · 21ms · Sources: EU EUDAMED, US FDA

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RCRP FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Immunology

I-neb In Vitro Test Disc Power 10

FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730004587·I-neb In Vitro Test Disc Power 10

GE

FDA UDI
Conmed Corporation·10653405002598·ECG CABLES

SURGICAL DRAPES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SOLAR SHOULDER OFFSET HUMERAL HEAD

FDA 510(k)
FDA Class 2 ·Orthopedic

6.0MM/10.0MM STEPPED DRILL BIT

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code HTO·February 28, 2013

ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 1, 2011

ELECSYS 2010 RACK

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 21, 2008

ZIMMER AIR DERMATOME

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code GFD·August 21, 2025

EVIS EXERA LLL COLONOVIDEOSCOPE

FDA Adverse Event
Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDF·May 5, 2022

EVIS EXERA LLL COLONOVIDEOSCOPE

FDA Adverse Event
Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDF·May 5, 2022

EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

FDA Adverse Event
Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDA·May 5, 2022

EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

FDA Adverse Event
Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDA·May 5, 2022

CTR73, 12X100 KII OPT ZTHR 6/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·December 1, 2023

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018