22 results
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25ms
·
Sources: EU EUDAMED, US FDA
ARIES® Flu A/B & RSV Assay
FDA 510(k)
FDA Class 2
·Microbiology
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK112201·DD tempMED are pre-colored dental milling blank...
Symmetry Rochester Ochsner
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482039861·Symmetry® Forceps, Rochester Ochsner, Straight,...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311612200·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321612200·
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962160725·ROCHESTER OSCHNER FORCEPS, 8", 1X2 TEETH, STR
URGOTUL AG
FDA 510(k)
FDA Unclassified
·Unknown
EXPLORER 4D TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 8, 2024
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 18, 2002
MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE S3 LEFT MEDIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·August 23, 2017
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 13, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 15, 2008
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220
FDA 510(k)
FDA Class 2
·Orthopedic
COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·July 30, 2025
COMPREHENSIVE REVERSE SHOULDER SYSTEM VIVACIT-E- HIGHLY CROSSLINKED POLYETHYLENE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·July 30, 2025
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM POLY LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·July 30, 2025
ZIMMER TRABECULAR METAL REVERSE PLUS SHOULDER SYSTEM GLENOSPHERE CENTRIC
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·July 30, 2025
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017