22 results
·
24ms
·
Sources: EU EUDAMED, US FDA
EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809265159285·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213015197·microSelectron Transfer Tube for 6F Flexibles (5)
Testa™ TP Pivoting Spacer System
FDA UDI
Spine Wave, Inc.·10840642176520·Interbody Implant, 27 mm (L) x 9 mm (H) x 7°
SHIMADZU COLLIMATOR R-20J
FDA 510(k)
FDA Class 2
·Radiology
RD-3008
FDA 510(k)
FDA Class 2
·Dental
LDR SPINE ROI-C INTERBODY FUSION DEVICE
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code ODP·April 10, 2013
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 2, 2011
PUMP MMT-712NAB PRDGM INSULIN BL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 12, 2008
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025
ARTEFILL DERMAL FILLER
FDA Adverse Event
Injury
·SUNEVA MEDICAL, INC.·Product code LMH·January 15, 2016
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026
5.5 EXP VERSE UNITIZED SET SCR
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·December 19, 2019
5.5 EXP VERSE SCR 6.0X45
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·December 19, 2019
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