15 results · 18ms · Sources: EU EUDAMED, US FDA

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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