29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Zethon
FDA UDI
ZETHON LIMITED·05059358050378·STERILE IRRIGATION TUBE KIT - C SHANK, SLIMLINE
Sklar®
FDA UDI
SKLAR CORPORATION·10649111367762·MAYO TRAY PERF191/8X125/8X3/4"
Sklar®
FDA UDI
SKLAR CORPORATION·30649111253328·MAYOTRAYPERF191/8X125/8X3/4PK6
Sklar
FDA UDI
SKLAR CORPORATION·30649111208809·MAYO TRAY PER 191/8X125/8 PK12
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PELVICFLEXER EXERCISE DEVICE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEARTMATE 3 SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·July 12, 2023
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 8, 2022
SACRAL NERVE IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·February 24, 2010
SACRAL NERVE IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MQQ·February 24, 2010
SACRAL NERVE IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·February 24, 2010
INTERSTIM IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MQQ·February 24, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS(SLC)·Product code JAA·April 30, 2013
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON ¿ IRVINE TECHNOLOGY CENTER·Product code HQC·September 15, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 10, 2011
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 15, 2022
UNK HIP FEMORAL STEM CORAIL
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code LZO·July 19, 2022
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024