15 results
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18ms
·
Sources: EU EUDAMED, US FDA
ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
3M™
FDA UDI
3M COMPANY·30605861069107·3M™ Crown Plier, 800417, Crimping, 1 Plier
3M™ ESPE™
FDA UDI
3M COMPANY·30605861032095·3M™ ESPE™ Crown Crimping Pliers, 800417
Denovo Dental Regular Crown Crimping Plier
FDA UDI
Denovo Dental, Inc.·00810059291652·
ADP,4,P800,S800,(2)1/4" N,TV,RAULAND
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828118668·ADP,4,P800,S800,(2)1/4" N,TV,RAULAND
CONVERTORS EQUIPMENT DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XKNIFE 5
FDA 510(k)
FDA Class 2
·Radiology
ULTAMET MTL INS NEUT 36MM 52OD
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code KWA·October 16, 2013
ARTICUL/EZE M 36MM +5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·October 16, 2013
BIODESIGN 4-LAYER TISSUE GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code FTM·April 3, 2014
LARGE NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·October 22, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007
regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021