21 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
FDA 510(k)
FDA Class 2
·General Hospital
Mepilex® Up
FDA UDI
Mölnlycke Health Care AB·07333350840679·Mepilex Up 10x20cm
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327359640·2.0MP LEFORT I PLATE,0MM ADVANCEMENT,R
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0122000·Assembly, Tab Breaker, Extended Tab
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707113339·Votion .018 MC UL2 +10T 8A 0O (10 PK) VOTION
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730007643·Votion 018 MC UL2 +10T 8A 0O (10 PK)
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101221·R CR Cemented Femoral Component Sz 2
FOCUS TOUCH CONCEPTION SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
1.5T INFINITY TWINSPEED MR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·January 12, 2017
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 29, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 15, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 9, 2013
DEKA LIPOAI
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025
4.3MM DRILL BIT QC/221MM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·September 4, 2019
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code FMZ·June 30, 2021
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·August 25, 2021
CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..
FDA Enforcement
Class II
·Terminated·Med Tec Inc·September 6, 2017
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·February 22, 2017
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020