13 results · 19ms · Sources: EU EUDAMED, US FDA

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ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler

FDA 510(k)
FDA Class 2 ·General Hospital

ELMED

FDA UDI
ELMED INCORPORATED·00842180124455·5 MM DIA., 36 CM INSULATED J-HOOK TIP ELECTRODE...

LINER F. MET.BACK GLEN.SMALL-R

FDA Adverse Event
Injury ·LIMACORPORATE SPA·Product code KWS·April 5, 2019

SSA-770A, APLIO ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

MCKESSON ANESTHESIA CARE

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

NC TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·August 16, 2011

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·September 25, 2014

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 9, 2013

Phoenix AP AST Indicator Bag, Catalog Number 246006

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·March 6, 2019

CustMbite, Model Number CBT-SRS-UL

FDA Enforcement
Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025