9 results
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21ms
·
Sources: EU EUDAMED, US FDA
SNORE TEC
FDA 510(k)
FDA Class 2
·Dental
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295245568·P.F.C. SIGMA RP CURVED TIBIAL INSERT TRIAL SZ 6...
UC-5000 Mobile X-Ray
FDA 510(k)
FDA Class 2
·Radiology
SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION
FDA 510(k)
FDA Unclassified
·Unknown
SCD EXPRESS COMPRESSION SYSTEM
FDA Adverse Event
Malfunction
·COVIDIEN·Product code JOW·January 25, 2013
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. TAIWAN·Product code INI·July 29, 2014
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·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