19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668108970·ARBISSER ANTERIOR CHAMBER CANNULA 27GA
Neocis Guidance System
FDA UDI
NEOCIS INC·00810004900479·Rayscan RCT700 Chin Rest
POINT 4 MODIFIED
FDA 510(k)
FDA Class 2
·Dental
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 8, 2025
Truliant CC
FDA UDI
Exactech, Inc.·10885862626219·TRULIANT AUG. BLOCK TRIAL SZ 3, 15MM DIST/10MM ...
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862287564·SZ 3 LGC AUG. BLCK TRIAL 15MM DIST/10MM POST
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862287663·
Truliant CC
FDA UDI
Exactech, Inc.·10885862613059·TRULIANT AUG. BLOCK SZ 3, 15MM DIST/10MM POST
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 23, 2013
TURBOHAWK
FDA Adverse Event
Malfunction
·EV3 INC.·Product code MCW·April 22, 2011
RIATA PASSIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
TITAN OTR NAR SCRO 16CM
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·September 6, 2018
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2021
TRI-LOCK BPS SZ 4 HI OFFSET
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2015
TRI-LOCK BPS SZ 7 STD OFFSET
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC·Product code KWA·November 4, 2015
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