51 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
FDA 510(k)
FDA Class 2
·Ophthalmic
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED
KaWe
FDA UDI
BV Medical·00845821020901·Specula, Disposable, 4.0mm (100 per pack, green)
APNEA GUARD
FDA 510(k)
FDA Class 2
·Dental
M2A ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
XIVE S PLUS
FDA Adverse Event
Injury
·FRIADENT GMBH·Product code DZE·January 7, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 30, 2010
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
EndoVive 3s Low Profile Balloon Kits Part Number: M00548520 (XMD P/N 70-0050-316) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
FDA Enforcement
Class II
·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016
Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 4 -Towel; 1 -19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Needle Safety Foam Block; 2 - 10cc Syringe L/L; 1 - Ruler; 2 4" x 4" Sponges in stacks of 5; 1 - " x 3" Bandage; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 -1% Lidocaine (5mL); 1 - CSR Wrap***Catalog Number: CG0305***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 22ga x 1-1/2" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 2 - 1% Lidocaine (5mL); 1 - " x 3" Bandage; 1 - Towel; 1 - CSR Wrap; 1 - Lidocaine Insert; 1 - Ruler with Protractor; 1 - 4" x 4" Sponges in stacks of 5***Catalog Number: CG00552***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 - 21ga x 1-1/2" Needle;1- 19ga x 1-1/2" Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - " x 3" Bandage; 2 - Towel; 1 - Fenestrated Drape; 2 - 15mL Specimen Tube; 2 - Specimen Label; 1 - Ruler; 1 - CSR Wrap***Catalog Number: GUTS1000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***Custom General Biopsy Tray for OMA North of Oklahoma City*** 1 - 60cc Syringe; 2 - 10cc Syringe L/L; 1 -18ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 50cm Extension Tube; 1 - 10% Povidone Iodine Swab Sticks (3Pkg); 1 - 1% Lidocaine (5mL); 1 - 3" x 3" Sponges is stacks of 5 (4-Ply); 1 - Fenestrated Drape; 1 - Towel; 1 - CSR Wrap***Catalog Number: CG0072***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010