19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
FDA 510(k)
FDA Class 2
·Microbiology
Neocis Guidance System
FDA UDI
NEOCIS INC·00810004900110·Planmeca Promax Chin Rest
IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
N PROTEIN STANDARD UY CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 30, 2024
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 23, 2021
RUSCH FIBEROPTIC LARYNGOSCOPE HANDLE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCW·June 21, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·April 23, 2013
ACCESS RUBELLA IGG
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LFX·May 2, 2011
OPTISENSE
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
G7 SCREW 6.5MM X 25MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·November 30, 2023
G7 OSSEOTI MULTIHOLE 60MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 3, 2023
BONE SCR 6.5X40 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·December 1, 2023
G7 SCREW 6.5MM X 50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·November 30, 2023
BONE SCR 6.5X50 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·December 1, 2023
PINNACLE SECTOR II CUP 60MM
FDA Adverse Event
Injury
·. DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·May 25, 2018
VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
FDA Enforcement
Class II
·Terminated·DJO, LLC·July 10, 2013
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018