37 results · 31ms · Sources: EU EUDAMED, 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