20 results · 21ms · Sources: EU EUDAMED, US FDA

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SOUNDSTAR™ CRYSTAL Ultrasound Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

Symmetry Surgical

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00841785113390·

Reddick Cholangiogram Catheter

FDA UDI
Lemaitre Vascular, Inc.·00840663101696·Reddick Cholangiogram Catheter, 4F, eIFU

Restore

FDA UDI
KEYSTONE DENTAL, INC.·D768L24005001K0·Temp Abutment

SacroFuse

FDA UDI
SPINEFRONTIER, INC.·00190361023326·Ø8MM FUSION SCREW, GEN II, SACROFUSE, 50MM

Restore

FDA UDI
KEYSTONE DENTAL, INC.·D768L24005000K0·Temp Abutment

NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE

FDA 510(k)
FDA Class 1 ·General Hospital

INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500

FDA 510(k)
FDA Class 2 ·Radiology

Trilogy®

FDA UDI
Zimmer, Inc.·00889024119338·

M/DN®

FDA UDI
Zimmer, Inc.·00889024041141·

PKG., AHTO IRRIGATION PUMP

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCX·December 3, 2019

SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420

FDA 510(k)
FDA Class 2 ·Orthopedic

COLLEAGUE VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·July 11, 2013

Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufactured by Stryker Endoscopy, San Jose, CA.

FDA Recall
Terminated ·Stryker Endoscopy·Product code LMD·December 11, 2009

LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

FDA Enforcement
Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

FDA Recall
Terminated ·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023

Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.

FDA Recall
Terminated ·Stryker Endoscopy·Product code LMB·February 15, 2008