28 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYDRO2, HS-75
FDA 510(k)
FDA Class 2
·Ophthalmic
Sledgehammer
FDA UDI
Keystone Industries·H66810004851·SC 5 lb Pwd & 1 Qt Liq Kit, Lt reddish pink
Affiniti
FDA UDI
TORNIER, INC.·00846832021161·BROACH
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282503673·TeWa CJ-Type 30100 Safe-T Sleeve: coated acupu...
TEWA
FDA UDI
asia-med GmbH·04251282510992·TeWa CJ-Type 30100 Safe-T Sleeve: coated acupu...
GeneXpert Dx System
FDA UDI
CEPHEID·07332940001377·Other Brand Name: GeneXpert Xpress System; Othe...
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004850·
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004850·
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORTSETT
FDA 510(k)
FDA Class 2
·General Hospital
HEYER-SCHULTE RADOVAN TISSUE EXPANDER, 400 CC
FDA Adverse Event
MENTOR CORP.·Product code LCJ·January 25, 1994
SURGITEK LARGE TISSUE EXPANDER, 800 CC
FDA Adverse Event
MEDICAL ENGINEERING CORP.·Product code LCJ·January 25, 1994
NATURAL Y VOGUE POLYURETHANE SILASTIC IMPLANT, SIZE 11/450GM
FDA Adverse Event
MEDICAL ENGINEERING CORP.·Product code FTR·January 25, 1994
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·March 12, 2013
ACCU-CHEK ® AVIVA
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·February 24, 2011
INRATIO
FDA Adverse Event
Injury
·HEMOSENSE, INC.·Product code JPA·February 21, 2008
ST-2 SOEHENDRA TANNENBAUM BILIARY STENT
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code FGE·July 14, 2022
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
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