14 results
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19ms
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Sources: EU EUDAMED, US FDA
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FPS
FDA UDI
Tyber Medical, LLC·00810040686122·Ø2.5mm Non-locking Screw, 19mm
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251019200·ceraMotion® Ti Opaque Modifier orange, 20 g / d...
SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SternaLock® 360 Sternal Closure System
FDA 510(k)
FDA Class 2
·Orthopedic
ANN PH NAIL RT 9X160MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·February 5, 2026
BLUNT TIP SCREW, ÿ 4X38MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·February 5, 2026
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·September 12, 2011
UNKNOWN HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·November 14, 2014
ELLIPS FX PHACO HANDPIECE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQC·July 29, 2013
POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code LJS·February 19, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021