1,535 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Biosyn
FDA UDI
Covidien LP·10884521032866·Monofilament Absorbable Suture
Biosyn
FDA UDI
Covidien LP·10884521032897·Monofilament Absorbable Suture
Biosyn
FDA UDI
Covidien LP·00884521032883·Monofilament Absorbable Suture
Biosyn
FDA UDI
Covidien LP·10884521032842·Monofilament Absorbable Suture
Biosyn
FDA UDI
Covidien LP·10884521032873·Monofilament Absorbable Suture
Biosyn
FDA UDI
Covidien LP·10884521032835·Monofilament Absorbable Suture
Biosyn
FDA UDI
Covidien LP·10884523004052·Monofilament Absorbable Suture
Biosyn
FDA UDI
Covidien LP·10884521032859·Monofilament Absorbable Suture
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
FDA Recall
Terminated
·Immuno-Mycologics, Inc·Product code GMJ·November 4, 2019
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
FDA Recall
Terminated
·Immuno-Mycologics, Inc·Product code GMJ·May 9, 2016
Antigens, Histoplasma Capsulatum, All
FDA classification
FDA Class 2
·Antigens, Histoplasma Capsulatum, All
DMJ 2000
FDA UDI
Digital Dental Laboratories, Inc·00810126380401·
Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2; 4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT, Model Number: WAL1901; 5) WALMART,HYDROCOLLOID,TOE,8CT, Model Number: WAL1902;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code NAD·February 19, 2025
GMI CORPORATION
FDA registration
GMI CORPORATION·6 products·🇺🇸 United States
GMC INC.
FDA registration
GMC INC.·1 product·🇨🇳 China
Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2; 4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT, Model Number: WAL1901; 5) WALMART,HYDROCOLLOID,TOE,8CT, Model Number: WAL1902;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 16, 2025
SENTECH GMI Corp
FDA registration
SENTECH GMI Corp·1 product·🇰🇷 South Korea
The Fitness Family
FDA UDI
GMB INTERNATIONAL LIMITED·00866066000312·A digital thermometer that measures body temper...
The Fitness Family
FDA UDI
GMB INTERNATIONAL LIMITED·00866066000305·A digital thermometer designed to measure body ...
GMI DENTAL IMPLANTOLOGY, S.L.
FDA registration
GMI DENTAL IMPLANTOLOGY, S.L.·3 products·🇪🇸 Spain