15 results · 23ms · 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.

AEQUALIS REVERSED SHOULDER PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·April 19, 2023

CoRoent

FDA UDI
Nuvasive, Inc.·00887517637017·CoRoent Ant TLIF PEEK, 13x12x28mm 15°

Oticon

FDA UDI
Oticon A/S·05707131257888·H16, MINIBTE 312 WL 85 CNB

OLYMPUS PREALBUMIN CALIBRATOR, ODR3029

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

KRYSTALRAD (ATAL8)

FDA 510(k)
FDA Class 2 ·Radiology

IMP TM 4.7MM MTX FULL, 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 27, 2024

TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

FDA Adverse Event
Injury ·COOK INC·Product code LJS·December 3, 2015

PWRD ECH FLEX 60MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 29, 2013

NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·June 11, 2011

PULMONETIC

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 203 /PULMONETIC SYSTEMS, INC.·Product code CBK·August 22, 2008

IMP TM 4.7MM MTX FULL, 10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 30, 2024

IMP TM 6.0MM MTX FULL, 10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 29, 2023

SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021