15 results
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34ms
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Sources: EU EUDAMED, US FDA
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Signature
FDA UDI
SILEX MEDICAL, LLC·B3315862000·Hook Scissors
Advance Dental Products
FDA UDI
The Atlanta Dental Supply Company·10850002458005·Advance Premium Non Woven 4X4 Sponge
Signature
FDA UDI
SILEX MEDICAL, LLC·B33158620000·Hook Scissors
Signature
FDA UDI
SILEX MEDICAL, LLC·B3315862020·Locking 10MM Babcock Grasping Forceps
Signature
FDA UDI
SILEX MEDICAL, LLC·B331586200045·Long Hook Scissors
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190660·Femoral Sizing Guide Bushing Neut/+2mm
Sphere Introducer
FDA UDI
KATENA PRODUCTS, INC.·00841668110836·CARTER SPHERE INTRODUCER
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0620000·Universal Removal Set
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH
FDA 510(k)
FDA Unclassified
·Unknown
PEDIATRIC DOUBLE SWIVEL CONNECTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
CUB PEDIATRIC CRIB
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 31, 2012
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·June 23, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012