15 results
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27ms
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Sources: EU EUDAMED, US FDA
ARTERIAL BLOOD SAMPLING KIT
FDA 510(k)
FDA Class 1
·General Hospital
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776134679·Malis type Bipolar Forcep, OL 152.4mm (6"), TW ...
Symmetry Par
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482127001·Symmetry® Scissors, Par, Curved, Razor Edge w/o...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776123956·Malis type Bipolar Forcep
GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2
FDA 510(k)
FDA Class 2
·Radiology
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS SLC·Product code JAA·December 30, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURING FACILITY·Product code KDJ·August 17, 2010
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025