48 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROFEMUR HIP SYSTEM MODULAR NECKS
FDA 510(k)
FDA Class 2
·Orthopedic
Bur PM2-70 80K Diam Ø3.5x80 St
FDA UDI
Bien-Air Surgery SA·17630055514858·
KNIFE HANDLE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896049918·KNIFE HANDLE #3L
BIO-KINETIX® THERMAL NITANIUM®ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707058524·.018 X .025 Upper Bio-Kinetix® Thermal Nitanium...
Monoblock Tibial Trial UC Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043544·
UA Healing Cap
FDA UDI
BICON, LLC·00813110026965·UA6 SP-TP Healing Caps (3)
TEMP-A-SURE
FDA 510(k)
FDA Class 2
·General Hospital
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
FDA 510(k)
FDA Class 2
·General Hospital
Widex
FDA UDI
Widex A/S·05706069727920·Widex EVOKE E-FA (Autumn Beige S-110 ) Telecoil...
Widex
FDA UDI
Widex A/S·05706069727524·Widex EVOKE E-FM (Autumn Beige S-110 ) RC coil
Widex
FDA UDI
Widex A/S·05706069729924·Widex EVOKE E-FP (Autumn Beige S-110 ) Telecoil...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
GMK FIXED CEMENTED TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·November 22, 2013
CROSSTIE INTRAOSSEOUS FIXATION SYSTEM
FDA Adverse Event
Malfunction
·CROSSROADS EXTREMITY SYSTEMS·Product code HWC·September 29, 2022
PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INCORPORATED·Product code HSB·May 8, 2013
S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER
FDA Adverse Event
Injury
·CONVATEC.·Product code EXE·September 12, 2014
D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 13, 2011
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023
Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·October 31, 2005
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 12, 2021