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