18 results · 22ms · Sources: EU EUDAMED, US FDA

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SPINEWORKS ANTERIOR LUMBAR DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517565402·CoRoent Ant TLIF PEEK, 13x13x34mm 0°

Oticon

FDA UDI
Oticon A/S·05707131260321·H10, MINIBTE 312 WL 85 STG

LEKSELL SURGIPLAN WITH IMAGEMERGE

FDA 510(k)
FDA Class 2 ·Neurology

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BATTERY POWERDRIVER P2

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code GEY·May 8, 2023

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 1, 2014

BIAXIAL AXLE WITH C CLIP

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDC·May 29, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 20, 2011

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 30, 2018

BATTERY POWERDRIVER P2

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code GEY·May 8, 2023

BATTERY POWERDRIVER P2

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code GEY·May 8, 2023

Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FFF·August 28, 2007

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

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

Achieva 1.5T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023