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

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HARDYDISK CEFTRIAXONE 30MCG

FDA 510(k)
FDA Class 2 ·Microbiology

Abiomed®

FDA UDI
Merit Medical Systems, Inc.·00884450838365·

Abiomed®

FDA UDI
Merit Medical Systems, Inc.·00884450732311·

Silverbolt/Mainframe

FDA UDI
Choice Spine, LP·10885862161185·

Datrend

FDA UDI
Datrend Systems Inc·B418PHASE380004400·Phase3 is the first Defibrillator / Pacer Analy...

Golden Isles Pedicle Screw System

FDA UDI
Intelivation, LLC·G079C2520004400·Curved Ti Rod, 440mm

PediFlex

FDA UDI
ORTHOPEDIATRICS CORP.·00841132119587·4.0mm Flex Nail Cap SS

MASEL Buccal Tubes

FDA UDI
Ortho Organizers, Inc.·00190707102241·BT 018 ROTH MINI SGL U7R DB (10)

VIVID, MODELS 40-A0001, 40-A0004, 40-A0006

FDA 510(k)
FDA Class 1 ·Dental

LATEX GLOVE, LOW POWDER

FDA Adverse Event
Malfunction ·CHESTER LABORATORIES, INC.·Product code LYY·January 21, 1994

INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CLINI-DENT

FDA 510(k)
FDA Class 1 ·Dental

MIO

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·September 2, 2024

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/20 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 13, 2023

CORE IMPACTION DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·March 12, 2013

MOOG CURLIN INFUSION ADMINISTRATION SET

FDA Adverse Event
Malfunction ·ZEVEX, INC·Product code FPA·February 17, 2011

VISIAN ICL (IMPLANTABLE COLLAMER LENS)

FDA Adverse Event
Injury ·STAAR SURGICAL·Product code HQL·February 21, 2008

AUTOSOFT 90

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017

BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015