14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
FRONT-LINE Field Sterilizer (FL135)
FDA 510(k)
FDA Class 2
·General Hospital
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·00699753454446·
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114308·SINSKEY IOL HOOK ANG (BX/3)
Disposable Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Veuron-Brain-pAb2
FDA 510(k)
FDA Class 2
·Radiology
2243801-1999-00040
FDA Adverse Event
Malfunction
·December 22, 1999
2243801-1999-00041
FDA Adverse Event
Malfunction
·December 22, 1999
2243801-1999-00042
FDA Adverse Event
Malfunction
·December 22, 1999
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 24, 2008
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
PKG, 5MM INSERT BIOPSY FORCEPS, SPOON W/PIN, 45CM, P/N 0250080581 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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021