33 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
FDA 510(k)
FDA Class 2
·Cardiovascular
PIIC CLASSIC UPGRADE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 24, 2024
ULTI GUARD HOME INSULIN SYRINGE CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
INSIGHT GENESIS
FDA 510(k)
FDA Class 2
·Neurology
PROSPACE PEEK IMPLANT 5 7X8X22MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013
TSPACE PEEK IMPLANT 26X11X7MM
FDA Adverse Event
Malfunction
·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
COMPACT EXCHANGE DEVICE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code KDJ·May 9, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·July 22, 2008
PROXIMAL HUMERUS, LEFT, 9X160MM
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code HSB·October 14, 2022
BLUNT TIP SCREW, 4X48MM
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code HSB·October 14, 2022
BLUNT TIP SCREW,4X48MM
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code HSB·October 14, 2022
BLUNT TIP SCREW, 4X50MM
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code HSB·October 14, 2022
BLUNT TIP SCREW, 4X50MM
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code HSB·October 14, 2022
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Enforcement
Class III
·Terminated·Angiodynamics, Inc.·December 28, 2016
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016
Stryker Reciprocating Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6206. Product is a linear cutting device used for cutting bone and bone related tissue.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008
Stryker Cordless Driver 3 Handpiece. Stryker Instruments, Kalamazoo, MI; REF 4300. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008
Stryker Precision Oscillating Tip Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6209. The product is an oscillating cutting device used for cutting bone and bone related tissue.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008
Stryker Sternum Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6207. The product is a linear cutting device used for cutting bone and bone related tissue including the sternum.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008