247 results
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50ms
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Sources: EU EUDAMED, US FDA
E SURGICAL, LLC
FDA registration
E SURGICAL, LLC·2 products·🇺🇸 United States
E Surgical
FDA UDI
E Surgical, LLC·00850053927041·4.0MM 50° ABLATOR
E Surgical
FDA UDI
E Surgical, LLC·00850053927010·4.0MM 90° ASPIRATING ABLATOR
E Surgical
FDA UDI
E Surgical, LLC·00850053927027·4.0MM 90° ABLATOR
E Surgical
FDA UDI
E Surgical, LLC·00850053927034·4.0MM 50° ASPIRATING ABLATOR
NURSE ASSIST, LLC
FDA Adverse Event
Injury
·NURSE ASSIST, LLC·Product code FRO·December 27, 2023
VOLISTA
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FSY·April 4, 2019
VOLISTA ACCESS
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FSY·May 6, 2019
HANAULUX 2005
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FSY·November 3, 2017
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·January 29, 2024
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW LLC·Product code MEB·January 9, 2013
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 8, 2013
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·February 5, 2020
HANAULUX 2005I
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FSY·May 16, 2017
SONICONE®O.R. SONICVAC
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·December 2, 2024
POWERLED
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FSY·March 5, 2019
BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·February 20, 2025
BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·February 20, 2025
Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027
FDA Recall
Terminated
·Sound Surgical Technologies, LLC·Product code GEI·December 21, 2010
regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - 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