10,000 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANOVO SURGICAL SYSTEM
FDA Adverse Event
Injury
·MOMENTIS SURGICAL LTD·Product code QNM·May 31, 2026
HOMINIS SURGICAL SYSTEM
FDA Adverse Event
Malfunction
·MEMIC INNOVATIVE SURGERY LTD.·Product code QNM·March 2, 2022
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System
FDA Recall
Open, Classified
·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
Mountable Electromechanical Surgical System For Transluminal Approaches
FDA classification
FDA Class 2
·Mountable Electromechanical Surgical System For Transluminal Approaches
HNM Medical dba HNM TOTAL RECON
FDA registration
HNM Medical dba HNM TOTAL RECON·212 products·🇺🇸 United States
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INMED GLOVES FACTORY
FDA registration
INMED GLOVES FACTORY·2 products·🇨🇳 China
ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
FDA 510(k)
FDA Unclassified
·Unknown
MEDEN-INMED, SP. Z O.O.
FDA registration
MEDEN-INMED, SP. Z O.O.·3 products·🇵🇱 Poland
NA
FDA UDI
SOUTHERN IMPLANTS (PTY) LTD·06009544037408·Titanium Abutment for Ø3.3 PROVATA, Non-Engaging
N/A
FDA UDI
SOUTHERN IMPLANTS (PTY) LTD·06009544041238·Abutment Peek Temp NE ø3.3 Provata
TruTorq Adaptor Sterile, Single Use
FDA UDI
Eca Medical Instruments·00857676008737·
TINNITUS THERAPY SYSTEM ANM T30 CR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INMED (WUXI) MEDICAL DEVICE CO.,LTD
FDA registration
INMED (WUXI) MEDICAL DEVICE CO.,LTD·17 products·🇨🇳 China
QNQ Design and Development Pvt. Ltd.
FDA registration
QNQ Design and Development Pvt. Ltd.·4 products·🇮🇳 India
TORQUE LIMITING POWER ADAPTOR 2NM, AO
FDA UDI
Biomet Orthopedics, LLC·00887868026362·
TORQUE LIMITING POWER ADAPTOR 2Nm, AO
FDA UDI
Biomet Orthopedics, LLC·00887868435829·
TruPWR Torque Limiting Attachment, 6 Nm
FDA UDI
Eca Medical Instruments·00857676008720·
Chiba Needle Marked
FDA UDI
REMINGTON MEDICAL, INC.·00813079020561·18ga (1.3mm) x 20cm