24 results · 20ms · Sources: EU EUDAMED, US FDA

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AVAVA™ Skin Treatment System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CoRoent

FDA UDI
Nuvasive, Inc.·00887517631862·CoRoent Ant TLIF Ti, 15x10x40mm 12°

Good Works

FDA UDI
Bosma Enterprises·00818634025371·Performance Pro Flex Nitrile Exam Glove Medium ...

Bradshaw Medical Inc.

FDA UDI
Bradshaw Medical, Inc.·00810019931185·BIT, TREPHINE 5.0MM 1/4 SQ

Grice Laparoscopic Suture Needle

FDA UDI
Lemaitre Vascular, Inc.·00840663102020·Grice Laparoscopic Suture Needle, eIFU

Endoluminal Occlusion System-EOS

FDA 510(k)
FDA Class 2 ·Cardiovascular

DR-HO'S Electro Therapy Conductive Gel

FDA 510(k)
FDA Class 2 ·Neurology

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 19, 2020

RESTORE RECHARGABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 3, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

GYNECARE PROLIFT +M ANTERIOR PELVIC FLOOR REPAIR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTP·July 26, 2013

Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

VITROS CHEMISTRY PRODUCTS GLU SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CGA·September 20, 2023

VITROS CHEMISTRY PRODUCTS GLU SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CGA·September 20, 2023

VITROS CHEMISTRY PRODUCTS GLU SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CGA·September 20, 2023

VITROS CHEMISTRY PRODUCTS GLU SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CGA·September 20, 2023

VITROS CHEMISTRY PRODUCTS GLU SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CGA·September 20, 2023

EasyPoint Needle, 25G x 5/8", REF: 82091

FDA Enforcement
Class II ·Ongoing·Retractable Technologies, Inc.·March 20, 2024

Arrow Three-Lumen CVC

FDA Enforcement
Class II ·Terminated·ARROW INTERNATIONAL Inc.·July 6, 2022

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020