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

Saw, Powered, And Accessories

Regulation 878.4820

0510(k)s in 12 months (2 all time)
0recalls in 12 months (16 all time)
0recalls that name a 510(k)
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Top companies in HAB

Company510(k)sRecalls
Smith & Nephew, Inc.06
Ascent Healthcare Solutions, Inc.03
Smith & Nephew, Inc. Endoscopy Division02
Zimmer, Inc.02
Arthrex, Inc.01
Linvatec Corp.10
Surgiquip, Inc.10
Zimmer Biomet, Inc.01
Zimmer Surgical Inc01
DateFirm and productCodeLinked 510(k)
Aug 27, 2018Arthrex, Inc.
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
Open, Classified		 HABNone listed
Feb 2, 2017Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
Terminated		 HABNone listed
Feb 2, 2017Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
Terminated		 HABNone listed
Feb 2, 2017Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704
Terminated		 HABNone listed
Feb 2, 2017Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703
Terminated		 HABNone listed
Feb 2, 2017Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702
Terminated		 HABNone listed
Feb 2, 2017Smith & Nephew, Inc.
Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
Terminated		 HABNone listed
Sep 28, 2016Zimmer Biomet, Inc.
Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Terminated		 HABNone listed
Dec 21, 2015Zimmer, Inc.
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
Terminated		 HABNone listed
Dec 21, 2015Zimmer, Inc.
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
Terminated		 HABNone listed
Oct 31, 2014Zimmer Surgical Inc
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece b
Terminated		 HABNone listed
Jul 1, 2011Smith & Nephew, Inc. Endoscopy Division
DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and o
Terminated		 HABNone listed
Jul 1, 2011Smith & Nephew, Inc. Endoscopy Division
DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resectio
Terminated		 HABNone listed
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
Terminated		 HABNone listed
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
Terminated		 HABNone listed
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
Terminated		 HABNone listed

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