17 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COAT-A-COUNT (TM) THEOPHYLLINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ReLine
FDA UDI
Nuvasive, Inc.·00195377035035·RELINE-C Drill Bit
Two Striper
FDA UDI
ABRASIVE TECHNOLOGY, INC.·B868C8900020·Dental Post Drill
Trimline
FDA UDI
ORMCO CORPORATION·00889989052381·LOWER LEFT SECOND MOLAR TRIMLINE BAND SIZE 2
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196563·AK3 4 in 1 A/P Cutting Block, size 2
Suture, Nonabsorbable, Synthetic, Polypropylene
FDA Pre-Market Approval
FDA Class 2
·POLYPROPYLENE SURGICAL SUTURE
Persona®
FDA UDI
Zimmer, Inc.·00889024558915·
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
FDA 510(k)
FDA Class 2
·General Hospital
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012
GIALLOY PA
FDA UDI
SRL Dental GmbH·ESRL58900021·Nichtedelmetall-Dental-Modellgusslegierung auf ...
MICRO PLUG SET
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code KRD·April 16, 2026
*
FDA Adverse Event
Malfunction
·KIMBERLY CLARK CORP.·Product code BTR·June 12, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·November 3, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 2012
IQon Spectral CT Model # 728332, computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018