17 results · 24ms · Sources: EU EUDAMED, US FDA

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G-FORCE TENODESIS SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

Clear Readers

FDA UDI
Diversified Products, Inc.·00842894127797·

Kalitec Disc Prep

FDA UDI
Kalitec Direct LLC·B07319K0861500·Pituitary, Up Biting, 3mm

MR-GUIDE 2000

FDA 510(k)
FDA Class 2 ·Radiology

ART POSTERIOR SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code NTW·May 1, 2026

16" CENTURY STERILIZER

FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code FLE·April 29, 2013

SARNS CENTRIFUGAL PUMP

FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code KFM·April 27, 2011

MICROSTAAR INJECTOR

FDA Adverse Event
Malfunction ·STAAR SURGICAL CO.·Product code KYB·July 24, 2008

UNSPECIFIED BD PAXGENE® BLOOD TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code PJE·June 13, 2025

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 23, 2026

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 31, 2026

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·February 9, 2026

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024