16 results · 21ms · Sources: EU EUDAMED, US FDA

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Intimate Rose Kegel Exercise System

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517576453·CoRoent Ant TLIF Ti, 9x13x36mm 4°

Contrast Line

FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207480·Contrast Line 30"(75cm) Female/Rotating Adapter...

EarQ

FDA UDI
Oticon A/S·05707131341600·G20, BTE 13 2.4G 85 C090 EARQ

SCREW,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HWC·June 9, 2017

SOLO MICROPUMP INSULIN DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

COBAS INTEGRA 800

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 7, 2008

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·June 27, 2013

3085SP SURGICAL TABLE

FDA Adverse Event
STERIS CORPORATION - MONTGOMERY·Product code FQO·August 5, 2011

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 2, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 3, 2015

PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025