22 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
FDA 510(k)
FDA Class 1
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189706·LEVAMED ACTIVE ANKLE SUP BLACK L I
Minute Stain - L.M.D. Elixirs
FDA UDI
Taub Products·D8370125210·Minute Stain's Larry’s Magical Denture Elixirs ...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120210·Assembly, Screwdriver, Extended Tab, Cannulated...
QUO
FDA UDI
FGX INTERNATIONAL INC.·00057800108238·
QUO
FDA UDI
FGX INTERNATIONAL INC.·00193033428108·
NICOLET VERSALAB
FDA 510(k)
FDA Class 2
·Radiology
SPARTAN MTS
FDA 510(k)
FDA Class 2
·Dental
CONSERVE(R) SUPER FINISH FEMORAL
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KXA·June 8, 2012
ILET BIONIC PANCREAS
FDA Adverse Event
Malfunction
·BETA BIONICS INC.·Product code QFG·January 29, 2026
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·March 15, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·March 10, 2011
PHILIPS INFORMATION CENTER
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code DRT·March 11, 2008
MALLORY/HEAD RADIAL 3-HOLE ACETABULAR SHELL 50MM/POROUS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·August 10, 2012
EXACTECH
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·March 28, 2022
BI-METRIC PRIMARY FEMORAL INTERLOK COLLARED 7.0 X 115MM TYPE I TAPER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·August 10, 2012
COOLSCULPTING SYSTEM
FDA Adverse Event
Injury
·ALLERGAN PLEASANTON·Product code OOK·April 29, 2021
MODULAR HEAD COMPONENT 32MM HEAD DIAMETER MINUS 3MM NECK TYPE I TAPER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDL·August 10, 2012
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018