10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
FDA 510(k)
FDA Class 1
·General Hospital
Bernafon
FDA UDI
Bernafon AG·05711584086261·ZR3 MNR, 2.4G NFM PB SABE/MSIL ZERENA 3
LUMINOS AGILE
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code OWN·March 5, 2025
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 26, 2013
GHOST II CATHETER
FDA Adverse Event
Malfunction
·NUMED CANADA, INC.·Product code LIT·July 19, 2011
SILICONE ADVANCED OPTIC LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 26, 2008
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018