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

Single Use Instrument Tray

Regulation 878.4800

0510(k)s in 12 months (0 all time)

0recalls in 12 months (38 all time)

2recalls that name a 510(k)

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Top companies in OJV

Company	510(k)s	Recalls
Medical Device Technologies, Inc.	0	31
Merit Medical Systems, Inc.	0	7

Date	Firm and product	Code	Linked 510(k)
Sep 20, 2017	Merit Medical Systems, Inc. Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078 Terminated	OJV	K031351
Sep 20, 2017	Merit Medical Systems, Inc. Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079 Terminated	OJV	K031351
Nov 19, 2016	Merit Medical Systems, Inc. Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A Terminated	OJV	None listed
Nov 19, 2016	Merit Medical Systems, Inc. Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G Terminated	OJV	None listed
Nov 19, 2016	Merit Medical Systems, Inc. Waste Management Kit. Catalog Number K10-04381AP Terminated	OJV	None listed
Nov 19, 2016	Merit Medical Systems, Inc. Manifold Kit. Catalog Number K09-11867AP Terminated	OJV	None listed
Nov 19, 2016	Merit Medical Systems, Inc. Fluid Management Set. Catalog Number K08-MP5159A Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*TLok Bone Marrow Tray*1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Specimen La Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech* Custom Bone Marrow Tray*1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Sy Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech* Custom Bone Marrow Tray for Louis Weiss Memorial Hospital*1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Nee Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*General Biopsy Tray* 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 - 21ga x 1-1/2" Needle;1- 19ga x 1-1/2" Filter Needle; 1 - 10% Povidone I Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom General Biopsy Tray for Lenox Hill Hospital* 4 -Towel; 1 -19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Needle Safety Foam Block; 2 - 10cc Syr Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom General Biopsy Tray for Lenox Hill Hospital* 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Ne Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom General Biopsy Tray for St. Johns Mercy Hospital* 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 -21ga x 1-1/2 Needle; 1 - 25ga x 5/8 Needle; 1 - 19ga x 1-1/2 Filter Needle; 1 - Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom General Biopsy Tray for Palos Community Hospital* 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 -18ga x 5cm Blunt Needle; 2 - Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom General Biopsy Tray for OMA North of Oklahoma City* 1 - 60cc Syringe; 2 - 10cc Syringe L/L; 1 -18ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 20ga x 1-1/2" Needle; 1 Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom General Biopsy Tray for University of Rochester Medical Center*1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 22ga x 1-1/2" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 1 Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom General Biopsy Tray for Emory University Hospital* 1 - CSR Wrap 48" x 48"; 1 - Fenestrated Drape; 4 -10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Chloraprep Applicator (3ml); 2 - Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom Bone Marrow Tray for High Point Regional Hospital* 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom Bone Marrow Tray for Hackensack University Medical Center* 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 2 -10cc Syringe L/L; 1 - M Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom Bone Marrow Tray* 1 - #11 Mini Scalpel; 1 -Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syr Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom Bone Marrow Tray for Tyler Hematology Oncology* 1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 25ga x 1-1/2" Needle; Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom Bone Marrow Tray for Kaiser Foundation Hospitals* 1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 1-1/2" Needle; 1 - 5cc Syringe L/L; 1 Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom Bone Marrow Tray* 1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1 - 23ga x 1" Needle; 1 - 18ga x 3-1/2" Needle; 1 - 25ga x 5/8" Needle; 3 - 10cc Syringe L/S; 2 - 1% Lidocaine (5 Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom Bone Marrow Tray for University of CA, Davis* 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 8g Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom Bone Marrow Tray for University of Chicago* 2- 20ga x 1 " Safety Needle; 1 21ga x 1-1/2" Safety Needle; 1 25ga x 5/8" Safety Needle; 1 - 10cc Syringe L/L; 2 - 20cc Syringe L/L; Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Custom Bone Marrow Tray for New York Hospital/Cornell Medical Center* 1 - 18ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 22ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 20cc Syrin Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Bone Marrow Tray*1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 16ga x 2.688" Bone Marrow Needle "I" Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Bone Marrow Tray*1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 15ga x 2.688" Bone Marrow Needle "I" Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*T-Lok Bone Marrow Tray*1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*T-Lok Bone Marrow Tray w/ Safety Needles*1 - #11 Retractable Scalpel; 1 - 21ga x 1-1/2" Safety Needle; 1 - 25ga x 5/8" Safety Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/ Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*T-Lok Bone Marrow Tray*1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Specimen Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*T-Lok Bone Marrow Tray*1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 -11ga x 4" Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*Bone Marrow Tray*1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Io Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*T-Lok Bone Marrow Tray*1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 6/7 Dram S Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*T-Lok Ecomony Bone Marrow Tray*1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11 Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*T-Lok Ecomony Bone Marrow Tray*1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11 Terminated	OJV	None listed
Nov 18, 2011	Medical Device Technologies, Inc. Angiotech*T-Lok Ecomony Bone Marrow Tray*1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 8g Terminated	OJV	None listed

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