593 results
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59ms
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Sources: EU EUDAMED, US FDA
GSHEN MEDICAL CO.,LTD
FDA registration
GSHEN MEDICAL CO.,LTD·1 product·🇹🇼 Taiwan
REBLOOM GRS VAGINAL TRAINERS
FDA UDI
Gshen medical CO., LTD.·04719961531008·• The Rebloom GRS Vaginal Trainer is intended f...
REBLOOM GRS VAGINAL TRAINERS
FDA UDI
Gshen medical CO., LTD.·04719961530506·• The Rebloom GRS Vaginal Trainer is intended f...
REBLOOM GRS VAGINAL TRAINERS
FDA UDI
Gshen medical CO., LTD.·04719961531503·• The Rebloom GRS Vaginal Trainer is intended f...
JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
FDA 510(k)
FDA Class 2
·General Hospital
Jiangsu Shenli Medical Production Co., Ltd.
Manufacturer
🇨🇳 China·2 Importers
Wujiang City Shen Ling Medical Device Co., Ltd.
Manufacturer
🇨🇳 China·155 Basic UDI-DIs·172 Devices·1 Importer·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH
JIANGSU SHENLI MEDICAL PRODUCTION CO.,LTD
FDA registration
JIANGSU SHENLI MEDICAL PRODUCTION CO.,LTD·6 products·🇨🇳 China
Wujiang City Shen Ling Medical Device Co.,Ltd.
FDA registration
Wujiang City Shen Ling Medical Device Co.,Ltd.·3 products·🇨🇳 China
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 Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 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 Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
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 Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 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 Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 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 Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 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 Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 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 Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 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 Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 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 Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
Tianzi
FDA UDI
Jiangsu Shenli Medical Production Co.,Ltd.·06935550811018·Disposable needle
27G×1/2
Rx only
Non-toxic
No...
DPS
FDA UDI
Jiangsu Shenli Medical Production Co.,Ltd.·06935550810011·DPS Bare Hypodermic Syringe,1ml Luer Lock,Needl...