20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ST AIA-PACK hsE2 Calibrator Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486019969·MCK PF TEMPLATE (3 RIGHT)
Humeris Shoulder
FDA UDI
FX SOLUTIONS·03701037303283·HUMERIS STEM TA6V SIZE 13 CEMENTED
OsteoMed
FDA UDI
OSTEOMED LLC·00845694004336·LOGIC Distractor, Right 36mm
Support Tube
FDA UDI
ELLIQUENCE, LLC·00846338004101·
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575390434·Surgical instrument guard, reusable - General I...
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023841·B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 25 MM
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
FDA 510(k)
FDA Class 2
·Radiology
DERMACYN WOUND CARE
FDA 510(k)
FDA Unclassified
·Unknown
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 10, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 10, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 13, 2011
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 12, 2020
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·July 19, 2019
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 14, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 30, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·May 28, 2020
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 26, 2018
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·September 17, 2019
MAGNETOM Verio Dot. Model Number: 10684333.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025