12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A.R.C. Laser Surgical Fibers and Probes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·20612479223695·Transducer Covers
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383539883·Gutta Percha Points is used to root canal filin...
ELI 250 ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U
FDA 510(k)
FDA Class 2
·Cardiovascular
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 13, 2011
AIM-ARM F/EXPERT R/AFN RETROGR F/SPIRAL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·June 11, 2013
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 12, 2008
SOEHENDRA STENT RETRIEVER
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 26, 2017
INNOVA IGS 530
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS SCS·Product code OWB·August 2, 2019
Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017