10 results · 18ms · Sources: EU EUDAMED, US FDA

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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