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ONTACT HEALTH CO., LTD.

FDA registration
ONTACT HEALTH CO., LTD.·2 products·🇰🇷 South Korea

Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUTTER COMMUNITY HOSPITAL (560214), SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), SSK TORRANCE MEMORIAL HOSPITAL (560394), SSK SURGERY ONE 20070208 (560428), SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), SSK HOAG MEMORIAL HOSPITAL (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK KAISER FOUNDATION HOSPITAL (560497), SSK THOMAS JEFFERSON UNIV HOSP (560513), SSK OVERLAKE MEDICAL CENTER (560521), SSK CUSTOM SPINAL TRAY (560523), SSK ORLANDO REGIONAL MED CENTER (560533), SSK BON SECOURS HEALTH SYS 20115122 (560538), SSK MANATEE MEMORIAL (560572), SSK MOUNT SINAI 27GA PENCAN SPINAL TRAY (560580), SSK SHANDS TEACHING HOSP. & CLINICS, INC (560584), SSK UNIVERSITY OF COLORADO (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK MAYO CLINIC - BUPIVACAINE TRAY (560609), SSK THE MEDICAL CENTER (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK EMORY ORTHO & SPINE HOSPITAL-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK MAYO CLINIC OB DEPT - SPINAL (560645), SSK BAPTIST HOSPITAL OF MIAMI (560646), SSK MERCY GILBERT MEDICAL CENTER (560647), SSK ST.MARY'S HOSPITAL (560648), SSK HARRIS HEALTH SYSTEM (560660), OHIO STATE U MEDICAL CTR SPINAL TRAY SSK (560667), ALBANY MEDICAL CENTER, SSK (560670), STONY BROOK HOSPITAL - SPINAL TRAY SSK (560672);

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code OFU·May 6, 2026

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleural space.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code JOL·June 11, 2024

Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid,

FDA Recall
Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OEZ·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code NWU·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac diagnostic and interventional procedures.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and catheters.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code DYB·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code DYB·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and interventional procedures.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code DYB·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code DYB·June 11, 2024

Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.

FDA Recall
Open, Classified ·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025

Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

FDA Recall
Open, Classified ·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K K05-01890D K05-01945A K05-01954A K05-02247A K05-02436B K05-02507 K05-02511A K05-02954 K05-02982A To support various vascular or cardiac diagnostic and interventional procedures.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code PXU·June 11, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Catheter Extractor is indicated for use with tunneled, double lumen hemodialysis catheters with cuff sizes ranging from 10.8 French to 14.5 French.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code ODY·June 11, 2024