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Panels › General, Plastic Surgery › Product code HWE · Class 1

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Regulation 878.4820

0510(k)s in 12 months (76 all time)
0recalls in 12 months (101 all time)
14recalls that name a 510(k)
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Top companies in HWE

DateFirm and productCodeLinked 510(k)
Sep 22, 2017Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument.
Terminated
HWENone listed
Sep 22, 2017Zimmer Biomet, Inc.
Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile
Terminated
HWENone listed
Feb 28, 2017Stryker Instruments Div. of Stryker Corporation
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Terminated
HWENone listed
Dec 1, 2016Synthes (USA) Products LLC
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Terminated
HWEK043310
Oct 18, 2016Stryker Instruments Div. of Stryker Corporation
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedu
Terminated
HWENone listed
Sep 27, 2016The Anspach Effort, Inc.
Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and ort
Terminated
HWEK043310
Sep 27, 2016The Anspach Effort, Inc.
Light Adaptor for Small Battery Drive and Small Battery Drive II.
Terminated
HWEK043310
Jul 12, 2016Synthes (USA) Products LLC
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist wit
Terminated
HWEK043310
Jul 12, 2016Synthes (USA) Products LLC
Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to
Terminated
HWENone listed
Jul 12, 2016Synthes (USA) Products LLC
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditiona
Terminated
HWENone listed
Jul 12, 2016Synthes (USA) Products LLC
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg.
Terminated
HWENone listed
Jul 12, 2016Synthes (USA) Products LLC
Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to
Terminated
HWENone listed
Jul 12, 2016Synthes (USA) Products LLC
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditio
Terminated
HWENone listed
Jul 12, 2016Synthes (USA) Products LLC
Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are u
Terminated
HWENone listed
Jul 12, 2016Synthes (USA) Products LLC
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instr
Terminated
HWENone listed
Jul 12, 2016Synthes (USA) Products LLC
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to
Terminated
HWENone listed
Jul 12, 2016Synthes (USA) Products LLC
Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used
Terminated
HWENone listed
Jul 12, 2016Synthes (USA) Products LLC
Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional In
Terminated
HWENone listed
Apr 26, 2016Greatbatch Medical
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T
Terminated
HWENone listed
Apr 26, 2016Greatbatch Medical
Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 T
Terminated
HWENone listed
Oct 22, 2015Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra
Terminated
HWEK964215
Oct 22, 2015Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra
Terminated
HWEK964215
Oct 22, 2015Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra
Terminated
HWEK964215
Oct 22, 2015Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra
Terminated
HWEK964215
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered mot
Terminated
HWENone listed
May 7, 2015Stryker Instruments Div. of Stryker Corporation
Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal B
Terminated
HWENone listed
Apr 30, 2015The Anspach Effort, Inc.
Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
Terminated
HWENone listed
Mar 23, 2015Synthes, Inc.
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smo
Terminated
HWEK043310
Feb 9, 2015Stryker Instruments Div. of Stryker Corporation
System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
Terminated
HWENone listed
Jan 12, 2015Medtronic Sofamor Danek USA Inc
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Terminated
HWEK111520
Nov 5, 2014Stryker Instruments Div. of Stryker Corporation
Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for S
Terminated
HWENone listed
Nov 5, 2014Stryker Instruments Div. of Stryker Corporation
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for S
Terminated
HWENone listed
Dec 31, 2013Synthes USA HQ, Inc.
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decort
Terminated
HWEK043310
Dec 2, 2011Synthes USA (HQ), Inc.
Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during s
Terminated
HWENone listed
Jul 25, 2011W & H DentalWerk Buermoos GMBH
Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples, Florida United States The system Is a modular electric system, consisting of a handpiece drive, various acces
Terminated
HWENone listed
Apr 4, 2011Linvatec Corp. dba ConMed Linvatec
POUCH/CARTON LABEL: ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Mad
Terminated
HWENone listed
Sep 13, 2010Stryker Instruments Div. of Stryker Corporation
Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA) The Impaction Bur Guard is intended to be used with the Impaction Drill. The drill is used for surgical procedures involving pr
Terminated
HWEK961970
Oct 26, 2009Synthes USA (HQ), Inc.
SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
Terminated
HWENone listed
Oct 1, 2009Linvatec Corp. dba ConMed Linvatec
MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only. ConMed Linvatec, 11311 Concept Blvd, Largo, FL 33773. The MC5057 Universal Cable, 12 ft, is used to connect electric handp
Terminated
HWENone listed
Sep 8, 2009Biomet, Inc.
Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.
Terminated
HWENone listed
Mar 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker Instruments, Kalamazoo, MI. Intended to be used with impaction Drill. Drill is used for surgical procedures invo
Terminated
HWEK961970

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