SCoV-2 Detect™ IgM ELISA

FDA UDI

INBIOS INTERNATIONAL, INC·B379COVEM1·

EL-Anti-SARS-CoV-2 IgM

FDA UDI

THERA-TEST LABORATORIES, INC·00854473003323·ANTI-SARS-CoV-2 IgM ANTIBODY ELISA TEST KIT, 96...

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

FDA registration

Canon Medical Systems Corporation·1 product·🇯🇵 Japan

i-STAT 1 Analyzer (Models 300 & 300-G)

FDA registration

ABBOTT POINT OF CARE INC.·1 product·🇺🇸 United States

cottony II tape

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ILESTO 7 HF-T, ILESTO 5 HF-T, IFORIA 7 HF-T IFORIA 5 HF-T, INVENTRA 7 HF-T (DF-1), INVENTRA 7 HF-T (DF4), IPERIA 7HF-T (

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Evia HF /HF-T; Entovis HF/ HF-T ; Edora 8 HF-T; Entira 8 HF-1; Etrinsa 8 HF-T; Epyra 8 HF-T; Eluna 8 HF-T; Edora 8HF-T Q

Mayo Hegar needle holder 20cm

FDA registration

SCHOBELL INDUSTRIAL LTDA·1 product·🇧🇷 Brazil

Meril Life Sciences Pvt. Ltd.

Manufacturer

🇮🇳 India·4172 Basic UDI-DIs·4171 Devices·25 Importers·TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), DNV Product Assurance AS, DNV Product Assurance AS, TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DNV Product Assurance AS, TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., DQS Medizinprodukte GmbH, TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), DQS Medizinprodukte GmbH, TURKISH STANDARDS INSTITUTION (TSE), DQS Medizinprodukte GmbH, TURKISH STANDARDS INSTITUTION (TSE), DNV Product Assurance AS, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., DNV Product Assurance AS, DNV Product Assurance AS, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., DNV Product Assurance AS, DNV Product Assurance AS, TURKISH STANDARDS INSTITUTION (TSE), TURKISH STANDARDS INSTITUTION (TSE), DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, TURKISH STANDARDS INSTITUTION (TSE), and TURKISH STANDARDS INSTITUTION (TSE)

Cinturón Abdominal T-1

Device

EU MDR · Eu Md Class 1 ·ORTOTEX MEDICAL S.L.·On the market·1 country

Arnes Chaleco T-1

Device

EU MDR · Eu Md Class 1 ·ORTOTEX MEDICAL S.L.·On the market·1 country

ImmunoCAP Allergen f449, Allergen Component rSes i 1, Sesame seed

FDA registration

PHADIA US INC.·1 product·🇺🇸 United States

ImmunoCAP Allergen f449, Allergen Component rSes i 1, Sesame seed

FDA registration

PHADIA AB·1 product·🇸🇪 Sweden

ImmunoCAP Allergen f449, Allergen Component rSes i 1, Sesame seed

FDA registration

PHADIA AB·1 product·🇸🇪 Sweden

Gynex

FDA UDI

GYNEX CORPORATION·GYNX102001·

Word

FDA UDI

COOK INCORPORATED·00827002554429·Word Catheter Silicone Bartholin Gland Balloon

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IPERIA 7 VR-T/INVENTRA 7 VR-T (DF-1); IPERIA 7 VR-T/INVENTRA 7 VR-T (DF4)

Currex CleatPro

FDA registration

Foundation Wellness International Co., LTD (FWIL)·1 product·🇻🇳 Vietnam

Action®

FDA UDI

ACTION PRODUCTS, INC.·00089904000088·

Bolus - Gel (film)

FDA UDI

CDR Systems Inc·00628341930116·Gel Bolus (with film)