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