13 results · 24ms · Sources: EU EUDAMED, US FDA

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EMBOLD™ Soft Detachable Coil System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Zavation

FDA UDI
Zavation LLC·00197157002749·CIF 14x18, 7 deg, -06

DUOFLEX COIL SUITE (1.5T)

FDA 510(k)
FDA Class 2 ·Radiology

EBI DYNAFIX COMPRESSION BONE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

SROM STM ST,36+6L NK,11X16X150

FDA Adverse Event
Injury ·DEPUY IRELAND ¿ REG. # 9616671·Product code LPH·April 11, 2016

S-ROM*SLEEVE PRX ZTT, 16D-LRG

FDA Adverse Event
Injury ·DEPUY IRELAND ¿ REG. # 9616671·Product code LPH·April 11, 2016

CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 17, 2008

SYSTEM 1000

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code KDI·September 1, 2011

TI MATRIX LOCKING CAP

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code NKB·July 16, 2013

Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777

FDA Enforcement
Class I ·Ongoing·Cardinal Health 200, LLC·February 14, 2024

BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

FDA Enforcement
Class II ·Ongoing·Staar Surgical Company·December 13, 2023

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