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

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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