17 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABL90 FLEX
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARGELITE 50 (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120197·Alloy other noble metal
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201970·Basic Endoscopy Procedure Kit
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319703687·Gruenwald (Jansen) Dressing Forceps 6-1/4" (16c...
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO DATACAPTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLE 22X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·July 17, 2024
LUMAX 540 HF-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NIK·May 20, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 25, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 6, 2011
AMPLATZER AMULET
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NGV·October 10, 2024
EAGLE EYE PLATINUM SHORT TIP
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·November 20, 2019
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015