21 results
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20ms
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Sources: EU EUDAMED, US FDA
PHOTOGRAPHIC EQUIPMENT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18122011·
RTI Allograft Paste
FDA UDI
Rti Surgical, Inc.·00898623002125·Allograft Paste 1cc
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·00699753532281·
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021428·Perfect Fit™Pediatric Effort Belt Kit: 2 sensor...
IV SET AN120 W/O BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·February 20, 2019
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Stratum Foot Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
TRANSVENE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·October 31, 2012
NIM EMG ENDOTRACHEAL TUBE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code BTR·August 18, 2010
PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020
PREMICRON GREEN 2/0 (3) 75CM HR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·June 28, 2019
PREMICRON GREEN 2/0 (3) 30CM SKR19(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·February 3, 2020
PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
PREMICRON GREEN 2/0 (3) 75CM HR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
IV SET AN120 W/O BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FRN·April 1, 2019
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021