5 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026