14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PANORAD, PANORAD SL
FDA 510(k)
FDA Class 2
·Radiology
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136026206·7450 SM 1410 W/HG LESS SMPL
MICROJET CRONO H
FDA 510(k)
FDA Class 2
·General Hospital
HY-BOND RESIGLASS
FDA 510(k)
FDA Class 2
·Dental
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S - 3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 26, 2024
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 15, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 24, 2014
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2011
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·August 17, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·April 8, 2025
TI-SU03 GC
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
BD SYRINGE 30ML LL S/C 56
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·November 9, 2021
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025