20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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