17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Audion ET dilation system
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
X-CORE
FDA UDI
Nuvasive, Inc.·00887517434241·X-CORE 2 Ti Core, Ø22x21-27mm
LEONE SPA
FDA UDI
LEONE SPA·08033707022213·CALIBRA BANDS 2ND MOLAR n.SUR 27
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482045688·Symmetry® Retractor, Ribbon, Malleable, 1 in Wi...
Spex
FDA UDI
SPEX LIMITED·09420051700956·Spex 2 Point Padded Hip Belt, Dual Centre Pull,...
PILAIRO NASAL PILLOWS MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
FOCUS RADIATION TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MECTALIF ANTERIOR LAG PLATE FLUSH H12 MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·March 9, 2023
MECTALIF ANTERIOR LAG PLATE FLUSH H12 MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·March 9, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 12, 2025
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·August 21, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 3, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 13, 2011
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
MRHK TIB INS 20MM XS/S S1/S2
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·October 28, 2025
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025