19 results · 20ms · Sources: EU EUDAMED, US FDA

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SMART TOUCH UVTHERAPY MULTIPLE MACHINE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Copper Ni-Ti - Archwire

FDA UDI
ORMCO CORPORATION·00889989028645·COPPER NITI 27 BAF 16X22L/L PK10

INTREPED, Intraosseous Fusion Device

FDA UDI
Auxano Medical LLC·00850055649507·INTREPED 09x12 implant

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321109120·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311109120·

Cosmolock

FDA UDI
Kalitec Direct LLC·B07310K1190120·Tray Insert 4, Cosmo MIS, Arcamed

AincA®

FDA UDI
ANESTHESIA ASSOCIATES, INC.·B005AAS1109120·Breathing Tube, 22mmM x 22mmF, Polyester/Silico...

DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE

FDA 510(k)
FDA Class 2 ·Neurology

ALARMVIEW WIRELESS DATA NETWORK SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

VUE PACS

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 4, 2020

PENTA

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS LLC (PR)·Product code NIQ·June 2, 2011

INRATIO PT/INR TEST STRIPS

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017

CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.

FDA Enforcement
Class II ·Terminated·Biocare Medical, LLC·May 6, 2015

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

FDA Enforcement
Class II ·Terminated·ConMed Corporation·April 4, 2018

PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications

FDA Enforcement
Class II ·Terminated·ConMed Corporation·May 22, 2013

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024