15 results · 24ms · 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.

ORTHOHUB EXTERNAL FIXATOR SOFTWARE

FDA 510(k)
FDA Class 2 ·Orthopedic

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015374445·STANDARD LOCKING SCREW L55.0MM D4.0MM

Thermoflect

FDA UDI
Encompass Group, L.L.C.·30612899003843·THERMOFLECT JACKET, XL, 25EA ...

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319740743·Johnson Osteotomy Clamp, 5-1/2" (14cm)

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015373943·STANDARD LOCKING SCREW L55.0MM D4.0MM STERILE

Apelo® / Apelo® MIS

FDA UDI
ATLAS SPINE, INC.·M68169001405500·5.5mm Fixed Cross Connector Kit

POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LINER: MPACT FLAT PE HC LINER 32/E

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 14, 2021

BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 19, 2021

OXF ANAT BRG RT LG SIZE 4 PMA

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·March 22, 2020

OT VERIO IQ METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 31, 2013

OT ULTRALINK METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·June 27, 2011

COBAS INTEGRA 800

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 28, 2008

MONARCH PLATFORM

FDA Adverse Event
Malfunction ·AURIS HEALTH, INC.·Product code EOQ·January 24, 2023