15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SERUM IRON-PTF-600
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78312011·Micro Sprint Bracket Roth .022" mand. 1+2 right...
TUCKER SCALER #300BP/349 SCLR
FDA UDI
W.H. Holden, Inc.·D9288312010·
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78312010101·Micro Sprint Bracket Roth .022" mand. 1+2 right...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78312010051·Micro Sprint Bracket Roth .022" mand. 1+2 right...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78312011001·Micro Sprint Bracket Roth .022" mand. 1+2 right...
TUCKER SCALER #300BP/CI-1S
FDA UDI
W.H. Holden, Inc.·D92883120110·
GN Otometrics A/S
FDA UDI
Natus Medical Denmark ApS·05713315003356·
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AU5800 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·May 23, 2014
OPTIVANTAGE DH
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code DXT·November 6, 2012
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
ASSURITY MRI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·September 13, 2022
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