28 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAP ENDO-EXO MEDULLARY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780804·LEVAMED ACTIVE ANKLE SUP SLVR R II
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506061141·WALTHER 5 1/4" Catheters For men 32 Fr.
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018601037·This product is an orthodontic bracket and is u...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112320·Tap, 4.75mm, Fixed Sleeve
3.2 x 230 mm Surgibit Drill
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215061982·The saleable unit (device count) is 1, there ar...
DELTA CER HEAD 11/13 32MM +6
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code LZO·November 15, 2024
CMC CABLE FIX
FDA 510(k)
FDA Class 2
·Orthopedic
JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001
FDA 510(k)
FDA Class 2
·General Hospital
VIKING
FDA Adverse Event
Death
·LIKO AB·Product code FSA·May 8, 2013
ARCHITECT TOTAL T3
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code CDP·September 23, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 2, 2011
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 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
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025