21 results · 31ms · Sources: EU EUDAMED, US FDA

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MODEL 5000 MULTIPLACE HYPERBARIC THERAPY

FDA 510(k)
FDA Class 2 ·Anesthesiology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·H65810027941·Feathered Gutta Percha Pts CC

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·10304040140533·Feathered Gutta Percha Pts CC

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040099629·Feathered Gutta Percha Pts CC

GRADIA®

FDA UDI
Gc America Inc.·D0470027941·GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.30...

GRADIA®

FDA UDI
Gc America Inc.·14548161322331·GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.30...

MODIFICATION TO MARSPO2, MODEL 2001

FDA 510(k)
FDA Class 2 ·Cardiovascular

EBI ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RESTORE ADVANCED

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·May 15, 2012

FOXCROSS PTA CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LIT·March 13, 2013

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·February 8, 2011

CELL-DYN SAPPHIRE ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 26, 2008

Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

VUELOCK SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

VEULOCK SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

VEULOCK SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

VUELOCK PLATE, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

VEULOCK SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2022

Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015