15 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

FIJI SUN FLUORESCENT TANNING UNIT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE

MaxFuse,VBR, 12 (D) x 14 (W) x 16 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468055950·12 (D) x 14 (W) x 16 (H)

WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

FDA 510(k)
FDA Class 2 ·Anesthesiology

GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

IDENTITY XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC, CRMD·Product code DXY·January 13, 2014

TRANSVENOUS

FDA Adverse Event
Malfunction ·GUIDANT PUERTO RICO BV·Product code NVN·July 6, 2011

CONCERTO CRT-D DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013

AMISTEM H, HA COATED STEM SIZE 4 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 2, 2017

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 22, 2016

VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·March 2, 2018

AERO LL FIXATION ANCHOR, 50MM

FDA Adverse Event
Malfunction ·STRYKER SPINE-US·Product code OVD·March 25, 2019

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016