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Panels › Neurology › Product code HBC · Class 2

Motor, Drill, Electric

Regulation 882.4360

1510(k)s in 12 months (27 all time)
0recalls in 12 months (39 all time)
37recalls that name a 510(k)
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Top companies in HBC

Decided510(k)Device and applicantCode
Sep 11, 2026K254174Surgical Power System
Guizhou Zirui Technology Co., Ltd., CN
HBC
Sep 20, 2024K233153Traus SSG10 Surgical System
Saeshin Precision Co., Ltd., KR
HBC
Sep 16, 2024K232938Traus SSG30 Surgical System
Saeshin Precision Co., Ltd., KR
HBC
Oct 31, 2022K213697ORiGO System
Bien-Air Surgery SA, CH
HBC
May 19, 2022K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
The Anspach Effort, Inc.
HBC
Apr 9, 2021K193630hekaDrill
Zethon, Ltd., GB
HBC
May 12, 2019K183515MR8 Drill System, Midas Rex MR8 ClearView Tools
Medtronic Powered Surgical Solutions
HBC
Jun 22, 2018K173066OSSEODUO Shaver and Drill System
Bien-Air Surgery SA, CH
HBC
May 15, 2017K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque ha
Medtronic Powered Surgical Solutions
HBC
Mar 28, 2017K163565MR8 Drill System
Medtronic Powered Surgical Solutions
HBC
Jul 22, 2016K152960ELAN 4 Motor System
Aesculap, Inc.
HBC
Jan 10, 2014K133604ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
The Anspach Effort, Inc.
HBC
Dec 17, 2013K132264PRIMADO2 TOTAL SURGICAL SYSTEM
Nakanishi, Inc.
HBC
Mar 29, 2013K130497D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION
Linvatec Corporation D/B/A Conmed Linvatec
HBC
Apr 29, 2009K083112PRIMADO
Nakanishi, Inc.
HBC
Apr 2, 2008K080444CONMED LINVATEC OSPREY DRILL SYSTEM
Conmed Linvatec
HBC
Apr 10, 2006K060260MICROPOWER HAND PIECE HIGH SPEED DRILL
Linvatec Corp.
HBC
Jan 18, 2006K053526MICROSPEED UNI MOTOR SYSTEM
Aesculap, Inc.
HBC
Nov 19, 2002K022986THE BIOPLATE BATTERY POWERED DRILL
Bioplate, Inc.
HBC
Oct 22, 2001K012457SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
Sodemsystems, CH
HBC
Oct 22, 2001K012453SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
Sodemsystems, CH
HBC
Aug 8, 2001K011444ANSPACH EMAX DRILL SYSTEM
The Anspach Effort, Inc.
HBC
Feb 20, 2001K003612MICROSPEED EC MOTORSYSTEM GD650/GD653
Aesculap, Inc.
HBC
Oct 6, 2000K002523ADVANTAGE DRIVE SYSTEM
Linvatec Corp.
HBC
Jan 16, 1998K972857SERVOTRONIC EC100 SYSTEM
Medicon EG
HBC
Aug 21, 1986K862989SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE
Entronics
HBC
Nov 2, 1981K812436450/800 DRILL
Black & Decker(Tm)
HBC

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