14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Epi-Stop Nasal Gel/epistaxis pack
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382607·Integra® Jarit® Dean Rongeur, 5-3/4", 5mm Bite,...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036035303·
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L23014200K0·Temp Abutment
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L23014201K0·Temp Abutment
THERMACOOL TC SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLIXENE IFG VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
UNKNOWN DEPUY ASR HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011
BRYAN® CERVICAL DISC SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code MJO·July 16, 2013
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
FDA Enforcement
Class III
·Ongoing·AGILENT TECHNOLOGIES INC./US·April 19, 2023
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014