18 results · 33ms · Sources: EU EUDAMED, US FDA

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Powder Free Vinyl Patient Examination Gloves, Yellow Color

FDA 510(k)
FDA Class 1 ·General Hospital

CoRoent

FDA UDI
Nuvasive, Inc.·00887517565976·CoRoent Ant TLIF PEEK, 14x13x34mm 0°

E.M Adams co, inc.

FDA UDI
E.M. ADAMS, INC.·10840200301722·SINGLE INSTRUMENT

E.M Adams co, inc.

FDA UDI
E.M. ADAMS, INC.·18100013401722·SINGLE INSTRUMENT

EZ SMART

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·June 7, 2019

TMJ SYSTEM LEFT FOSSA COMPONENT, MEDIUM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·June 7, 2019

TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·June 7, 2019

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 3, 2013

PROFEMUR(R) RENAISSANCE(R) STEM

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·June 29, 2011

PROMUS PREMIER?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 6, 2014

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

33CM DORSEY GRASPER FORCEPS, P/N 0250080319. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021