247 results · 50ms · Sources: EU EUDAMED, US FDA

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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