29 results
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21ms
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Sources: EU EUDAMED, US FDA
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741096167·Catheter Placement Kit
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501396·TeWa 5CB-Type 2225 Speed Pak: coated acupunctu...
TEWA
FDA UDI
asia-med GmbH·04251282508715·TeWa 5CB-Type 2225 Speed Pak: coated acupunctu...
GeneXpert Dx System
FDA UDI
CEPHEID·07332940006754·XPERT, GENEXPERT DX SYSTEM
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129742·ECLIPSE PRO,DEFIB CABLE,PX,10 SNAP,AHA
CORTEK CYSTOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GSI 2000 MIDDLE EAR ANALYZER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/17 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 16, 2020
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 29, 2024
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code KXT·March 12, 2013
THYMAPAD STIMULUS ELECTRODES
FDA Adverse Event
Malfunction
·SOMATICS, LLC·Product code GXC·February 18, 2011
PFC SIGMA STAB INS SZ3 10MM
FDA Adverse Event
Injury
·DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 19, 2008
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·July 29, 2021
8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·April 30, 2021
SMR REVERSE FINNED HUMERAL BODY
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·February 4, 2022
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
FDA Recall
Terminated
·I-Flow Corporation·Product code MEB·May 8, 2012
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
FDA Enforcement
Class I
·Terminated·I-Flow Corporation·September 5, 2012
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013
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