22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Talos-C(HA) Cervical Intervertebral Body Fusion Devices
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517637550·CoRoent Ant TLIF PEEK, 14x12x34mm 15°
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071134181·14FR x 2.3 cm x 45 cm Low Profile Transgastric-...
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071101725·14FR x 2.3 cm x 45 cm Low Profile Transgastric-...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970508·
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
FDA 510(k)
FDA Class 2
·Dental
EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
FDA 510(k)
FDA Class 2
·Clinical Chemistry
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071116873·14FR x 2.3 cm x 45 cm Low Profile Transgastric-...
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071134198·14FR x 2.3 cm x 45 cm Low Profile Transgastric-...
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 5, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 15, 2013
TWINFIX TI 2.8 SUTURE ANCHOR
FDA Adverse Event
Injury
·SMITH & NEPHEW·Product code MBI·January 4, 2007
UNITIP CATHETER FOR HR GI
FDA Adverse Event
Malfunction
·UNISENSOR USA INC·Product code FFX·January 16, 2015
BAIR HUGGER / 3M
FDA Adverse Event
Injury
·3M·Product code DWJ·November 23, 2016
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015