166 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.

Promisemed Triple Safety Pen Needle

FDA 510(k)
FDA Class 2 ·General Hospital

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112670·BARRON CORNEAL PUNCH 9.0MM

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113400·IMPLANT KNIFE 4.0MM (BX/5)

MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

FDA 510(k)
FDA Class 2 ·Cardiovascular

RANDOX C-REACTIVE PROTEIN CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025

SITTER SELECT

FDA Adverse Event
Malfunction ·J. T. POSEY CO.·Product code KMI·February 13, 2009

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023

GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2024

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2026

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code JEY·July 2, 2013

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024

HF UNIT "ESG-400"

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GEI·November 19, 2023

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2023

GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 21, 2023

ELECTROSURGICAL GENERATOR "ESG-400"

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GEI·July 8, 2022

GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 4, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 18, 2024