18 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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