43 results
·
30ms
·
Sources: EU EUDAMED, US FDA
VERTEX SEALAND L/C ORTHODONTIC SEALANT
FDA 510(k)
FDA Class 2
·Dental
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105470·Zirlux Titanium Abutment 4.5 mmH compatible wit...
STORK INSTRUMENTE GMBH
FDA registration
STORK INSTRUMENTE GMBH·40 products·🇩🇪 Germany
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105070·Draw Rod, Primal T- Handle
ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
FDA 510(k)
FDA Class 2
·Microbiology
ATR TECNIKA
FDA 510(k)
FDA Class 1
·Dental
0009613348-2024-010547
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·August 9, 2024
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 14, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·March 1, 2011
KIMBERLY-CLARK UNIVERSAL EXTREMITY DRAPE
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK CORPORATION·Product code KKX·February 19, 2008
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 17, 2024
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 5, 2025
Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.
FDA Recall
Terminated
·Medrad Inc·Product code JAK·October 7, 2005
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 30, 2022
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·February 26, 2020
LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024