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

Tray, Surgical

Regulation 878.4800

0510(k)s in 12 months (22 all time)
11recalls in 12 months (111 all time)
9recalls that name a 510(k)
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Top companies in LRP

DateFirm and productCodeLinked 510(k)
Jul 28, 2011Deroyal Industries, Inc. Lafollette
DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 20641391, 21092240, 21950988,
Terminated
LRPNone listed
May 20, 2011Deroyal Industries, Inc. Lafollette
Kits and Trays containing lubricant: GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF 50-13272.05, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235,
Terminated
LRPNone listed
May 20, 2011Deroyal Industries, Inc. Lafollette
Kits and Trays containing alcohol swabstick/prep pad: GEO-MED BIOPSY TRAY, V A MED CTR MARTINSBURG, REF 89-7617.01 Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB
Terminated
LRPNone listed
May 20, 2011Deroyal Industries, Inc. Lafollette
Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R) AMNIOCENTESIS TRAY, LINK DREW LACO HOSP, REF 50-11656.02, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries
Terminated
LRPNone listed
Feb 15, 2011Ethicon Endo-Surgery Inc
FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays. I
Terminated
LRPK061156
Dec 27, 2010DePuy Spine, Inc.
Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile Product Code: 2883-90-420 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior
Terminated
LRPNone listed
Dec 27, 2010DePuy Spine, Inc.
Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code: 2883-90-400 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screw
Terminated
LRPNone listed
Dec 27, 2010DePuy Spine, Inc.
Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile Product Code: 2883-90-000 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery
Terminated
LRPNone listed
Oct 8, 2009Alphatec Spine, Inc.
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Terminated
LRPNone listed
Apr 30, 2009Tri-State Hospital Supply Corporation
Tri-State Centurion Endoscopy Tray, sterile, 10 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder MNS4635.
Terminated
LRPNone listed
Feb 23, 2008Tri-State Hospital Supply Corporation
Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among othe
Terminated
LRPK012736

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