16 results
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23ms
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Sources: EU EUDAMED, US FDA
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033701·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, COC150, MET500, MOR300 PCP,
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001242·INSTANT-VIEW Multi-Drugs of Abuse Urine Test
AM...
Phonak
FDA UDI
Phonak AG·07613275359396·Phonak Sky V90-SP (beige)
SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDO-GLIDE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
2.0MM CANNULATED DRILL BIT/QC 150MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTW·November 12, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
HERCULES 3 STAGE ESOPHAGEAL BALLOON
FDA Adverse Event
Malfunction
·WINSTON-COOK MEDICAL INC.·Product code KNQ·February 11, 2011
IMPLANTIUM
FDA Adverse Event
Injury
·DENTIUM·Product code DZE·April 25, 2008
EDWARDS COMMANDER DELIVERY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 17, 2021
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021