23 results · 23ms · 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.

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

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

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964012707·The ENDO CARRY-ON Procedure Kit contains all of...

LoFric®

FDA UDI
Wellspect AB·07333387033730·Single Use Urinary Catheter LoFric Nelaton 16" ...

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001440·artVeneer life upper anteriors, BIM, D2

LoFric®

FDA UDI
Wellspect AB·07392532131844·Single Use Urinary Catheter LoFric Nelaton 16" ...

ODYSSEY®

FDA UDI
Microport Orthopedics Inc.·M684K00124401·

DIAMOND

FDA UDI
SPINAL ELEMENTS·00840916162078·4MM CERVICAL PLATE TAP

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361008477·PedFuse Respond, CNL, 7.0mm x 40mm

HARDYDISK CEFTRIAXONE 30MCG

FDA 510(k)
FDA Class 2 ·Microbiology

IDS5 IMAGE DISPLAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·April 19, 2026

KINETRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 11, 2012

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 25, 2011

NOVAPLUS ALCOHOL PREP PAD

FDA Adverse Event
Malfunction ·TRIAD/NOVATION·Product code LKB·February 19, 2008

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO VILLALBA·Product code PJS·February 11, 2026

PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.

FDA Enforcement
Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

FDA Enforcement
Class II ·Terminated·Oxus America, Inc.·February 13, 2013

PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

FDA Enforcement
Class II ·Terminated·TEI Biosciences·January 24, 2018

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013