18 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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