20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
FDA 510(k)
FDA Class 3
·Cardiovascular
Implant Prosthetics
FDA UDI
Preat Corporation·00842092102749·Astra®-compatible Lilac 4.5/5.0mm 17° Multi-Uni...
Oxygen Tubing
FDA UDI
WESTMED, INC.·00709078014079·Oxygen Tubing Kink Resistant 21' Clear Pliable ...
Procure
FDA UDI
Twin Med, LLC·10840330700525·Oxygen Tubing Kink Resistant 21' Clear Pliable ...
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159028744·Dennis Multi-Purpose Clamp
Silverbolt/Mainframe
FDA UDI
Choice Spine, LP·00840996170192·SILVERBOLT,SCREW,POLYAXIAL,6.5X80
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361009016·PedFuse Reset, CNL, 7.0mm x 80mm
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
FDA 510(k)
FDA Class 1
·General Hospital
BEHRING COAGULATION SYSTEM, MODEL BCS
FDA 510(k)
FDA Class 2
·Hematology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 16, 2025
Synergy MSK Ultrasound Scanner
FDA UDI
Clarius Mobile Health Corp·07540205000373·
VUELOCK PLATE, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 13, 2013
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·February 18, 2011
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·February 22, 2008
DISP.TROCAR THRD.W.DILATING PIN 12/110MM
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code GCJ·July 9, 2019
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018