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

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LCI OPTION FOR INNOCOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

SPIRA-C

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPC1020470·Trial 12.5mm x 16mm Lordotic 7°, 11mm

SPIRA-L

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPL1020470·Trial, Bi-Convex, 20° Lordotic, 22 x 60mm, 12mm

SPIRA®-A Integrated

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020470·SPIRA®-A Integrated,Trial, 26x34mm, 25° Lordoti...

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166008·MIS Acetabular Reamer, 47mm

RIVA STAR SILVER DIAMINE FLUORIDE

FDA Adverse Event
Injury ·SDI LIMITED·Product code LBH·February 13, 2019

3I CALCIUM SULFATE BONE CEMENT

FDA 510(k)
FDA Class 2 ·Dental

DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2

FDA 510(k)
FDA Class 2 ·Cardiovascular

UniTip Catheter

FDA UDI
Unisensor AG·07640172971956·

PAINSMART IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 22, 2013

HUDSON INCENTIVE SPIROMETER

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code BWF·April 13, 2011

UNIVERSAL DRIVER

FDA Adverse Event
Malfunction ·ABBOTT SPINE·Product code HXX·August 7, 2008

FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HTO·December 17, 2014

Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

FDA Enforcement
Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

Model Number L101, ESSENTIO DR SL Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Hemodialysis Delivery System, Software Version 2.x.

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021