11 results
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20ms
·
Sources: EU EUDAMED, US FDA
LEKSELL STEREOTACTIC SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR28021401·Titanol Low-Force arches Straight-Arch-F. mand....
XPERT MRSA/SA BLOOD CULTURE ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
MENICON PROGENT REMOVER
FDA 510(k)
FDA Class 2
·Ophthalmic
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 23, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013
ENDOPATH** XCEL* STABILITY SLEEVE FOR BLADELESS TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 17, 2010
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
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
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024