8 results · 23ms · Sources: EU EUDAMED, US FDA

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Sacro Lumbar Support

Device
EU MDR · Eu Md Class 1 ·OPPO Medical Corp.·On the market

USTAR II Knee System

Device
EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·On the market·1 country

Biokey Anchorage screw

Device
EU MDD · Eu Md Class 2b ·BOMEI Co.,Ltd·On the market·1 country

SciVision Biotech Inc.

System producer
🇹🇼 Taiwan

Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

FDA Enforcement
Class II ·Ongoing·Visgeneer, Inc.·September 10, 2025

Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

FDA Enforcement
Class II ·Ongoing·Visgeneer, Inc.·September 10, 2025

Lazervida 10W diode laser cutter and engraver with Lazervida shield.

FDA Enforcement
Class II ·Ongoing·Flux Technology Inc.·June 11, 2025

1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;

FDA Enforcement
Class II ·Ongoing·UNIMAX MEDICAL SYSTEMS INC·September 25, 2024