12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ASTRA T2, ASTRA T4, ASTRA T6
FDA 510(k)
FDA Class 3
·Cardiovascular
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
FDA 510(k)
FDA Class 2
·Radiology
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
FDA 510(k)
FDA Class 2
·Dental
TAPERLOC STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 12, 2018
HEARTSTART
FDA Adverse Event
Other
·LAERDAL MEDICAL A/S·Product code LDD·July 18, 2005
CER BIOLOX DELTA HEAD,
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·June 12, 2018
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·January 17, 2013
SECURE ACUTE CARE BED 3/01
FDA Adverse Event
Malfunction
·Product code FNL·December 6, 2010
ACCENT DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
5MM HEX FLEXIBLE SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·December 1, 2023
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021