125 results
·
129ms
·
Sources: EU EUDAMED, US FDA
EXACTECH BIOLOGICS
FDA Adverse Event
Malfunction
·REGENERATION TECHNOLOGIES, INC.·Product code NUN·November 7, 2005
UNK - CONSTRUCTS: PLATE/SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KWP·December 31, 2020
UNK - PLATES: RECONSTRUCTION
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·December 31, 2020
UNK - SCREWS: TRAUMA
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·December 31, 2020
TRITON CANISTER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code PBZ·April 27, 2023
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·April 17, 2019
TORQUE LIMITING DRIVER HANDLE
FDA Adverse Event
Injury
·TECOMET, INC.·Product code LXH·November 17, 2023
THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·April 4, 2019
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Blue Belt Technologies MN·August 28, 2013
INTELISWAB COVID-19 RAPID TEST
FDA Adverse Event
Malfunction
·ORASURE TECHNOLOGIES, INC·Product code QKP·January 12, 2023
INTELISWAB COVID-19 RAPID TEST
FDA Adverse Event
Malfunction
·ORASURE TECHNOLOGIES, INC·Product code QKP·January 12, 2023
THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·March 18, 2024
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·May 10, 2023
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·October 27, 2022
FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code OAD·March 12, 2024
INSERTION INSTR.W/BALL-SHAPED TRIGON STR
FDA Adverse Event
Malfunction
·AESCULAP IMPLANT SYSTEMS·Product code LXH·February 24, 2017
CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH -
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DYB·April 16, 2019
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK INC·Product code MIH·January 30, 2018
Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008
Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Towel; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing***Catalog Number: BMET1104ATL***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