10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110928·STERILIZING CASE SINGLE VR
Accu-Beam
FDA UDI
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL·B1779205170·Re-usable fiberoptic handpiece for lasers.
17ga...
DEPUY PULSE CERVICAL CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES DUAL-OPENING USS
FDA 510(k)
FDA Class 2
·Orthopedic
FENESTRATED BIPOLAR FORCEPS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 17, 2013
ENDO CLIP 5MM CLIP APPLIER
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code FZP·December 6, 2010
ACCENT DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·February 17, 2021
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