10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICRO SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
CHARNLEY
FDA UDI
DEPUY INTERNATIONAL LTD·10603295245391·CHARNLEY Modular Trial Femoral Prosthesis CDH
CHARNLEY
FDA UDI
DEPUY INTERNATIONAL LTD·10603295245407·CHARNLEY MODULAR Trial Stem Flanged 35
SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
FDA 510(k)
FDA Class 1
·General Hospital
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2014
11.5FR X 13.5CM MAHURKAR KIT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MPB·January 24, 2013
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·January 18, 2011
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