16 results
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27ms
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Sources: EU EUDAMED, US FDA
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P
FDA 510(k)
FDA Class 2
·General Hospital
PEEK Corpectomy
FDA UDI
Nuvasive, Inc.·00887517623034·PEEK Corp Core, Ø12x13mm
CORAIL
FDA UDI
DEPUY (IRELAND)·10603295478645·CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA CO...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293050·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049422·K-Wires, Double diamond, .062-inch (1.6mm) diam...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012801·K-Wires, Double diamond, .062-inch (1.6mm) diam...
K-Wire w. double end lanzet point 1.57mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM712130·K-Wire w. double end lanzet point
1.57mm...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484566·K-Wire w. double end lanzet point _x000D_...
One Touch Condom with Benzocaine
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAMLOG LOGFIT PROSTHETIC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CORAIL AMT SZ13 STD COL
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code MEH·April 22, 2025
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 1, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 26, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·July 31, 2014
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
FDA Enforcement
Class II
·Terminated·Battle Creek Equipment Co.·November 9, 2016
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017