22 results · 24ms · 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.

X-PSI Knee System

FDA 510(k)
FDA Class 2 ·Orthopedic

M.U.S.T. MINI POLYAXIAL SCREW

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·August 27, 2025

MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·April 6, 2018

MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·March 8, 2022

HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM

FDA 510(k)
FDA Class 1 ·Anesthesiology

TBA

FDA 510(k)
FDA Class 2 ·General Hospital

MUST MINI ROD TI 3.5 X 80MM (STERILE)

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·July 13, 2021

MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·July 14, 2020

COULTER LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 14, 2013

LCS COMPLETE FEM CEM L STD+

FDA Adverse Event
Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·September 19, 2008

MEMORY II DOUBLE LUMEN EXTRACTION BASKET

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code LQR·July 28, 2021

MUST MINI POLYAXIAL SCREW 3.5 X 18 FULL THREAD + NUT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·October 27, 2022

MUST MINI ROD REDUCTION DEVICE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·September 27, 2019

JK Bariatric Beds, True Air Technologies, Inc.

FDA Enforcement
Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

M.U.S.T. MINI POLYAXIAL SCREW

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·August 11, 2025

MUST MINI POLYAXIAL SCREW 3.5 X 20 FULL THREAD + NUT

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWP·February 2, 2018

Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

FDA Enforcement
Class II ·Terminated·Allergan Inc·July 29, 2015

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025