14 results · 19ms · Sources: EU EUDAMED, US FDA

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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