11 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Trio-CT Triple Lumen Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THERMOPLASTIC INSTRUMENT TRAY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075122·THERMOPLASTIC INSTRUMENT TRAY SINGLE DEEP TRAY ...
mambo™ modular cervical plate system
FDA UDI
Ulrich GmbH & Co. KG·04052536008452·mambo rescue screw yellow, ø 4 mm, length 19 mm
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
FDA 510(k)
FDA Class 2
·General Hospital
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·August 15, 2012
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 3, 2008
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 21, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 28, 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