21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Evie Med Ring
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074494197·CD HORIZON SPIRE - OUTER CASE
MaXcess
FDA UDI
Nuvasive, Inc.·00887517197177·MaXcess 4 Blade, 90mm Left
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022637·FPS 2.0mm Subcondylar Plate
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101223·ELLIS FOREIGN BODY SPUD
OsteoMed
FDA UDI
OSTEOMED LLC·00845694076845·FPS 2.0 Subcondylar Plate Sterile Qty 2
HDL-EX SEIKEN ASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TSV BELLATEK ENCODE HEALING ABUTMENT 3.5MM (D) X 3.8MM (P) X 5MM (H)
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code NHA·January 4, 2021
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code JDI·November 22, 2013
SUMMIT POR TAPER SZ5 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 16, 2013
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 16, 2013
PINNACLE SECTOR II CUP 58MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 16, 2013
PINN MAR NEUT 36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 16, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 21, 2008
REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·August 17, 2011
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·July 22, 2013
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014