17 results
·
38ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CORTRAK* 2 Equilateral Enteral Access System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169599161·TRIAL 2191340 O25 IB 27MM 6 DEG 12X40
CoRoent
FDA UDI
Nuvasive, Inc.·00887517568076·CoRoent Ant TLIF PEEK, 9x11x34mm 0°
Walgreens
FDA UDI
WALGREEN CO.·00311917014029·WALGREENS ANTI EMBOLISM STOCKING THIGH HIGH SZ ...
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780418740·Integra® Miltex® Lempert Elevator 7", Curved Bl...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111386398·DRESSING FCP FLUTED HDL 4.5"
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365121357·
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819134000201·EXMRC MBT 018/LL4 - 12T 2A
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819134000101·EXMRC ROTH 018/LL4 - 17T - 1A 4D
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008
CELL-DYN 3500 CS ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·September 20, 2010
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 29, 2023
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022