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