16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intimate Rose Kegel Exercise System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517576453·CoRoent Ant TLIF Ti, 9x13x36mm 4°
Contrast Line
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207480·Contrast Line 30"(75cm) Female/Rotating Adapter...
EarQ
FDA UDI
Oticon A/S·05707131341600·G20, BTE 13 2.4G 85 C090 EARQ
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 9, 2017
SOLO MICROPUMP INSULIN DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 7, 2008
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code KWA·June 27, 2013
3085SP SURGICAL TABLE
FDA Adverse Event
STERIS CORPORATION - MONTGOMERY·Product code FQO·August 5, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 2, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 3, 2015
PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025