11 results
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18ms
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Sources: EU EUDAMED, US FDA
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
FDA 510(k)
FDA Class 2
·Anesthesiology
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110904·TIP GUARDS VENTED ORANGE PACK OF 100
GDC POWER SUPPLY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010
TriVerse X-Ray Digital Template, PS Femur
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215115753·
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 6, 2011
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Malfunction
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 22, 2014
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024