12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LEIBINGER IMF SCREW
FDA 510(k)
FDA Class 2
·Dental
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111154·FOX EYE SHIELD GARTER ASST COLOR PK/50
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108253·BARRAQUER NEEDLE HOLDER CURVED
CHARNLEY
FDA UDI
DEPUY INTERNATIONAL LTD·10603295245308·CHARNLEY Modular Trial Femoral Prosthesis Round...
COMFORT SCOOTER MODEL LY-EW406
FDA 510(k)
FDA Class 2
·Physical Medicine
630C ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 23, 2014
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·January 24, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·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
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020