47 results · 25ms · 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.

HILLA DIGITAL TRANSFERS

FDA 510(k)
FDA Class 2 ·Dental

Comprehensive® Shoulder System

FDA UDI
Biomet Orthopedics, LLC·00880304213050·

N/A

FDA UDI
HANS RUDOLPH, INC.·00874750003600·76 V2 ASSY LARGE 22ID NO HG

Plateau Spacer System

FDA UDI
Life Spine, Inc.·00190837045593·Wedge Distractor, 10mm

SPIRO PD

FDA 510(k)
FDA Class 2 ·Anesthesiology

KPS-I, THE KIDNEY PERFUSION SOLUTION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·August 5, 2019

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2023

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 10, 2013

PINNACLE MTL INS NEUT40IDX60OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 24, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 24, 2011

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·September 6, 2019

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025

AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·April 28, 2014

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·February 5, 2019

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 27, 2019

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026