12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
X-CORE
FDA UDI
Nuvasive, Inc.·00887517269393·X-CORE Mini Core, Ø12mm 15-20mm
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295241393·P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM ST...
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Erbes CO2 Tubing/Cap Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 14, 2013
PARADYM
FDA Adverse Event
Malfunction
·SORIN BIOMEDICA CRM S.R.L.·Product code NIK·January 17, 2011
COULTER LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 28, 2014
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·April 15, 2024
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 23, 2024
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024