37 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TMINI Miniature Robotic System (TMINI 1.1)
FDA 510(k)
FDA Class 2
·Neurology
LCP
FDA UDI
Synthes GmbH·10886982165572·3.5MM LCP T-PLATE 3H HEAD/ 3H SHAFT/52MM-OBLIQU...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022620·FPS 2.0mm x 7 Hole Y Plate
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·00678467508058·Customized Reusable Anorectal 24 Channel Catheter
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·00678467006950·24-Channel Customized Reusable Esophageal Catheter
OsteoMed
FDA UDI
OSTEOMED LLC·00845694076821·FPS 2.0 7 Hole Y Plate Sterile Qty 2
NRFit® Caps, Male and Female Neuraxial Tip Caps
FDA 510(k)
FDA Class 2
·General Hospital
CARDIOSTATION-100 (CS-100)
FDA 510(k)
FDA Class 2
·Cardiovascular
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·February 8, 2024
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL·Product code LTI·November 21, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 22, 2013
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm; TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; TJC4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·August 18, 2021
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·December 26, 2024
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·January 6, 2025