49 results · 20ms · 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.

MERIDIAN-II AND MERDIAN-PLUS

FDA 510(k)
FDA Class 2 ·Neurology

TruForm

FDA UDI
Rmo, Inc.·00885797099679·MAN MOLAR BDS PEDO ASST 100

Gensini™

FDA UDI
MEDTRONIC, INC.·00763000199203·WVN CATH 001347 10PK 8F 125CM GENSINI

Gensini™

FDA UDI
MEDTRONIC, INC.·00613994964380·WVN CATH 001347 10PK 8F 125CM GENSINI

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001347·artVeneer life upper anteriors, ITL, C2

TensCare

FDA UDI
TENSCARE LIMITED·05033435135776·The Nouri Digital Electric Breast Pump is a pow...

Diagon

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO0013470·"Off-Set, Bi-Convex, 10mm x 39mm x 18mm, Obliq...

GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ENHANCED POLYETHYLENE KNEE PROSTHESES

FDA 510(k)
FDA Class 2 ·Orthopedic

SOCKET WRENCH FOR VEPTR NUT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HXC·August 26, 2024

SOCKET WRENCH FOR VEPTR NUT

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXC·August 19, 2022

SOCKET WRENCH FOR VEPTR NUT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HXC·September 28, 2022

STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·September 1, 2020

GORE EXCLUDER AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·March 6, 2013

SMARTSTITCH WITH MAGNUMWIRE SUTURE CARTRIDGE

FDA Adverse Event
Other ·ARTHROCARE CORPORATION·Product code KOG·February 18, 2011

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 19, 2008

SOCKET WRENCH FOR VEPTR NUT

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXC·March 23, 2021

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

AUTOSOFT 30

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 23, 2024

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025