13 results · 20ms · 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.

Xenograft Bovine Bone Particulate

FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·00636257127964·30-40 MV FOR MEN SEL CALF STD TAN III

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·00636257125786·30-40 MV FOR MEN CLSC CALF STD TAN III

Holder, Needle, TC, acc. Mayo-Hegar 24cm

FDA UDI
Geister Medizintechnik GmbH·04057034064429·Holder, Needle, TC, acc. Mayo-Hegar 24cm ...

URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

INFUSET FLOW CONTROL EXTENSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

IMPLANT, ENDOSSEOUS, ROOT-FORM

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·August 28, 2025

TANDEM T: SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·November 4, 2014

ISOFLEX LEAD

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011

INCEPTA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013

CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)

FDA Adverse Event
Death ·CURRENT HEALTH LTD·Product code MSX·September 9, 2024

Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024