12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Renovis S141 Lumbar Interbody Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550216·GENUMEDI PT KNEE SUP SILVER R EW VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814299·GENUMEDI PT SILVER R VI
E+R,Ever Ready First Aid
FDA UDI
Wenzhou Caretek Medical Device Co., Ltd.·06975871430222·SINGLE HEAD STETHOSCOPE YELLOW
ASSIST HEADER CLEANER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TROPHON CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·May 26, 1999
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code MXC·January 13, 2014
TM MONOBLOCK TIBIA
FDA Adverse Event
Injury
·ZIMMER TMT·Product code JWH·May 29, 2013
POLAR CARE KODIAK
FDA Adverse Event
Other
·BREG, INC·Product code ILO·June 20, 2011
PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. 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
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024