14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128557·Ultra Tibial Insert CS, Size 3 x 13mm
LP Low Profile
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746091018·DB BKT LP V-SLOT UR LAT 022 T+12 A+9 R=0
NA
FDA UDI
Zimmer, Inc.·00889024078451·
NA
FDA UDI
Zimmer, Inc.·00889024078468·
NA
FDA UDI
Zimmer, Inc.·00889024104389·
NA
FDA UDI
Zimmer, Inc.·00889024104396·
MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS
FDA 510(k)
FDA Class 1
·Anesthesiology
VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD
FDA 510(k)
FDA Class 2
·Dental
FRESENIUS 2008K
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE·Product code KDI·June 23, 2014
1-DAY ACUVUE TRUEYE NARAFILCON A
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·December 13, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 30, 2013
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