14 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LIFELIFT MODELS ONE AND TWO
FDA 510(k)
FDA Class 1
·General Hospital
TLX
FDA UDI
Nuvasive, Inc.·00887517824905·TLX Implant, 7x11x26mm 20°
SpineWand
FDA UDI
MORGAN STEER ORTHOPAEDICS LIMITED·05060696460019·Perc DLG Convenience Pack inc 17 gauge 8” Crawf...
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470004489·PERC DLG
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470004472·PERC DLR SPINE WAND SURGICAL DEVICE
SpineWand
FDA UDI
MORGAN STEER ORTHOPAEDICS LIMITED·05060696460002·Perc DLR Convenience Pack Inc 17 gauge 6” Crawf...
uWS-MR
FDA 510(k)
FDA Class 2
·Radiology
IMMULISA ANCA SCREEN ELISA
FDA 510(k)
FDA Class 2
·Immunology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 2, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 16, 2012
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 15, 2015
DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·September 7, 2022
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021