12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Q21
FDA 510(k)
FDA Class 2
·Neurology
Oticon
FDA UDI
Oticon A/S·05714464008032·AGXO F400 MINIRITE R C044
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
FDA 510(k)
FDA Class 2
·Cardiovascular
EVIS EXERA III VIDEO SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 3, 2014
GO BED PLUS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 17, 2011
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 3, 2013
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LPH·October 17, 2025
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025