ClearanceBrief
Panels › Ear, Nose, Throat › Product code ERL · Class 2

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Regulation 874.4250

0510(k)s in 12 months (91 all time)
0recalls in 12 months (29 all time)
26recalls that name a 510(k)
Get daily alerts for ERLSample briefCSV

Top companies in ERL

DateFirm and productCodeLinked 510(k)
Dec 15, 2021Medtronic Xomed, Inc.
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC
Terminated
ERLK081277
K081475
Sep 11, 2020Bien-Air Surgery Sa
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues a
Open, Classified
ERLK083720
Sep 11, 2020Bien-Air Surgery Sa
Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as
Open, Classified
ERLK143492
Sep 11, 2020Bien-Air Surgery Sa
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat
Open, Classified
ERLK143492
Sep 11, 2020Bien-Air Surgery Sa
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blade
Open, Classified
ERLK083720
Sep 11, 2020Bien-Air Surgery Sa
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
Open, Classified
ERLK792159
Jun 12, 2020Medtronic Xomed, Inc.
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.
Terminated
ERLNone listed
Oct 6, 2016The Anspach Effort, Inc.
Foot Control without Switches, SC2100 Product Usage: Electric system
Terminated
ERLK011444
Oct 6, 2016The Anspach Effort, Inc.
Foot Control, SC2100 Product Usage: Electric system
Terminated
ERLK011444
Oct 6, 2016The Anspach Effort, Inc.
Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
Terminated
ERLK011444
Oct 6, 2016The Anspach Effort, Inc.
XMAX Motor, High Strength Hose Product Usage: Pneumatic system
Terminated
ERLK965080
Oct 6, 2016The Anspach Effort, Inc.
XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
Terminated
ERLK965080
Mar 28, 2016The Anspach Effort, Inc.
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bon
Terminated
ERLK131053
Mar 28, 2016The Anspach Effort, Inc.
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping
Terminated
ERLK131053
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems
Terminated
ERLK965080
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
Terminated
ERLK965080
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
Terminated
ERLK965080
Apr 30, 2014Laurimed LLC
PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which acces
Terminated
ERLK133133
Mar 20, 2014Stryker Instruments Div. of Stryker Corporation
2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision C
Terminated
ERLK011381
Jan 16, 2014The Anspach Effort, Inc.
Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
Terminated
ERLK011444
K965080
Jan 9, 2014The Anspach Effort, Inc.
***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Terminated
ERLK965080
Jan 9, 2014The Anspach Effort, Inc.
***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Terminated
ERLK965080
Jul 16, 2013Stryker Instruments Div. of Stryker Corporation
RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (
Terminated
ERLK040300
Jul 16, 2013Stryker Instruments Div. of Stryker Corporation
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling,
Terminated
ERLK040300
Jul 16, 2013Stryker Instruments Div. of Stryker Corporation
Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone rel
Terminated
ERLK040300
Nov 13, 2009Medtronic Xomed, Inc.
Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA. Distributed by: Medtronic Powered Surg
Terminated
ERLK002828
Feb 13, 2008The Anspach Effort, Inc.
Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.
Terminated
ERLNone listed
Feb 13, 2008The Anspach Effort, Inc.
Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.
Terminated
ERLNone listed
Feb 13, 2008The Anspach Effort, Inc.
Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.
Terminated
ERLK831756
K965080

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.