17 results · 22ms · Sources: EU EUDAMED, US FDA

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EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control

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

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704512519·

PATIENT MONITOR, MODEL PM50

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACCIN TOTAL KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ACE MEDICAL AF W/AS 550 X 1-14ML/HR CPNB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code MEB·February 12, 2020

TOTAL ASR FEM IMP SIZE 49

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·June 21, 2013

ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·July 21, 2011

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code NIQ·September 30, 2008

INSET II

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 11, 2025

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 10, 2021

KIT BD MAX ENTERIC VIRAL PANEL

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PCH·October 3, 2022

Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

FDA Enforcement
Class I ·Terminated·Galemed Corporation·January 1, 2020

Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·July 16, 2014

Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

FDA Enforcement
Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018