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Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with Smart Assist, Impella $.0/LD

419 P37,GE,2LD

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828123488·419 P37,GE,2LD

2020 P37,HR,2LD

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828124775·2020 P37,HR,2LD

Frame

FDA registration
Wenzhou New Standing Eyewear Co., Ltd.·1 product·🇨🇳 China

Sunglasses

FDA registration
Wenzhou New Standing Eyewear Co., Ltd.·1 product·🇨🇳 China

Optical

FDA registration
Wenzhou New Standing Eyewear Co., Ltd.·1 product·🇨🇳 China

Reading glass

FDA registration
Wenzhou New Standing Eyewear Co., Ltd.·1 product·🇨🇳 China

HAYFEVER HELMET

FDA 510(k)
FDA Class 2 ·General Hospital

Synergy Health Ede BV

FDA registration
Synergy Health Ede BV·1 product·🇳🇱 Netherlands

Synergy Health Ede BV

FDA registration
Synergy Health Ede BV·1 product·🇳🇱 Netherlands

Natus10057 (ED) - Dantec DCN Disposable Concentric Needle

FDA registration
Synergy Health Ede BV·1 product·🇳🇱 Netherlands

Synergy Health Ede BV

FDA registration
Synergy Health Ede BV·1 product·🇳🇱 Netherlands

Synergy Health Ede BV

FDA registration
Synergy Health Ede BV·1 product·🇳🇱 Netherlands

L15-7io, S12-4, S5-1, S7-3t, S8-3, X7-2t

FDA registration
Modality Group Ltd·3 products·🇬🇧 United Kingdom

Xario 200

FDA registration
Modality Group Ltd·3 products·🇬🇧 United Kingdom

12L-RS; 12S-RS; 3Sc-RS; 4C-RS; 8C-RS; 9L-RS; C1-5-RS; C2-9-RS; IC9-RS; ML6-15-RS; RAB2-6-RS; RIC5-9A-RS

FDA registration
Modality Group Ltd·3 products·🇬🇧 United Kingdom

PLT- 1204MV PVT-375MV PVT-712BT PLT-705BTF PET-508MA PVT-3 82BT PVT-745BTF PVT-705BTH PET-S510MB PVT-382MV PVT-745BTH

FDA registration
Modality Group Ltd·3 products·🇬🇧 United Kingdom

Synergy Health Ede BV

FDA registration
Synergy Health Ede BV·1 product·🇳🇱 Netherlands

IMDS (ED) - Micro Rx

FDA registration
Synergy Health Ede BV·1 product·🇳🇱 Netherlands

SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS

FDA registration
Modality Group Ltd·3 products·🇬🇧 United Kingdom