50 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
FDA 510(k)
FDA Class 2
·General Hospital
Quantum Blue Nitrile Exam Gloves
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063754898·Quantum Blue nitrile exam gloves, cobalt blue, ...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193114347·HA PEEK EVOS Straight, ,14mmx11mmx 26mm , FLAT ...
neoWave C
FDA UDI
XENIX MEDICAL LLC·00818345023840·Cervical Inserter Draw Rod
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100140·Caddie, Large Implants and Instruments
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex
NA
FDA UDI
STRYKER CORPORATION·04546540861252·Coaxial High Flow Tip with Soft Shield
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100140·Implant Tray, Cosmolock, Arcamed
NA
FDA UDI
STRYKER CORPORATION·04546540144188·High Flow Tip
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100140·Implant Tray
INSTANT-VIEW METHADONE URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STA- COAG CONTROL (N+ABN) PLUS
FDA 510(k)
FDA Class 2
·Hematology
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025
GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·October 18, 2023
GMK HINGE AND REVISION TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2025
GMK HINGE AND REVISION TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025
GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·March 22, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 13, 2014