20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OCCLUFAST ROCK
FDA 510(k)
FDA Class 2
·Dental
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 34mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665008784·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410240340·Anterior Closing Wedge Osteotomy Guide, 24mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710430240340·Medial Malleolar Osteotomy Guide, 24mm x 34mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420240340·Anterio Lateral Closing Wedge Osteotomy Guide, ...
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD ALCOHOL SWABS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·February 15, 2024
MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·March 29, 2018
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·March 27, 2013
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·February 15, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008
ALIF SCREWDRIVER UNIVERSAL JOINT
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·January 15, 2016
MECTALIF ANTERIOR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·May 6, 2025
MECTALIF ANTERIOR TI-PEEK CAGE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·January 4, 2018
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
FDA Recall
Open, Classified
·O & M HALYARD, INC.·Product code FXX·November 8, 2024
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
FDA Recall
Open, Classified
·O & M HALYARD, INC.·Product code FXX·November 8, 2024
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018