ClearanceBrief
Panels › General, Plastic Surgery › Product code FSM · Class 1

Tray, Surgical, Instrument

Regulation 878.4800

0510(k)s in 12 months (76 all time)
4recalls in 12 months (40 all time)
3recalls that name a 510(k)
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Top companies in FSM

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Howmedica Osteonics Corp.
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Open, Classified
FSMNone listed
Oct 15, 2026Howmedica Osteonics Corp.
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Open, Classified
FSMNone listed
Oct 15, 2026Howmedica Osteonics Corp.
TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
Open, Classified
FSMNone listed
Oct 15, 2026Howmedica Osteonics Corp.
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Open, Classified
FSMNone listed
Sep 10, 2025Encore Medical, LP
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of pa
Open, Classified
FSMK233481
Sep 12, 2024Medical Action Industries, Inc. 306
Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50
Open, Classified
FSMNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS P
Open, Classified
FSMNone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
Open, Classified
FSMNone listed
Apr 25, 2023Aesculap Implant Systems LLC
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for plac
Open, Classified
FSMNone listed
Jan 11, 2023Stradis Healthcare
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Open, Classified
FSMNone listed
Jan 11, 2023Stradis Healthcare
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Open, Classified
FSMNone listed
Nov 24, 2021Howmedica Osteonics Corp.
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalizati
Open, Classified
FSMNone listed
Jun 10, 2019Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Terminated
FSMNone listed
Jun 10, 2019Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Terminated
FSMNone listed
Nov 28, 2018Zimmer Biomet, Inc.
Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilizati
Terminated
FSMNone listed
Nov 28, 2018Zimmer Biomet, Inc.
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization
Terminated
FSMNone listed
Mar 5, 2018Synthes (USA) Products LLC
Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
Terminated
FSMNone listed
Mar 5, 2018Synthes (USA) Products LLC
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Terminated
FSMNone listed
Mar 5, 2018Synthes (USA) Products LLC
Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
Terminated
FSMNone listed
Dec 21, 2016Synthes (USA) Products LLC
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Terminated
FSMNone listed
Nov 15, 2016Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
Terminated
FSMNone listed
Oct 8, 2015Stryker Craniomaxillofacial Division
Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed i
Terminated
FSMNone listed
Oct 6, 2015Zimmer, Inc.
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation,
Terminated
FSMNone listed
Aug 20, 2015Synthes (USA) Products LLC
Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Unive
Terminated
FSMNone listed
Aug 20, 2014Zimmer, Inc.
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent
Terminated
FSMNone listed
Aug 20, 2014Zimmer, Inc.
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent
Terminated
FSMNone listed
Aug 13, 2013SpineFrontier, Inc.
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift L
Terminated
FSMNone listed
Aug 8, 2013SpineFrontier, Inc.
Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates t
Terminated
FSMK121060
Aug 1, 2013SpineFrontier, Inc.
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw
Terminated
FSMNone listed
Jul 5, 2013SpineFrontier, Inc.
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants
Terminated
FSMK092815
Mar 28, 2013Cardinal Health
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system f
Terminated
FSMNone listed
Mar 28, 2013Cardinal Health
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x
Terminated
FSMNone listed
Mar 28, 2013Cardinal Health
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and
Terminated
FSMNone listed
Mar 28, 2013Cardinal Health
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Ste
Terminated
FSMNone listed
Mar 28, 2013Cardinal Health
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 C
Terminated
FSMNone listed
Mar 28, 2013Cardinal Health
Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30
Terminated
FSMNone listed
Mar 28, 2013Cardinal Health
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6
Terminated
FSMNone listed
Mar 28, 2013Cardinal Health
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6
Terminated
FSMNone listed
Mar 28, 2013Cardinal Health
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Steri
Terminated
FSMNone listed
Mar 21, 2012Customed, Inc
Incision and Drainage Tray, catalog# 900-774
Terminated
FSMNone listed

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