12 results
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27ms
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Sources: EU EUDAMED, US FDA
RANDOX BENZODIAZEPINE CLASS ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496050179·RED WELLNESS 70 LEGGINGS, SIZE XL, MOSTO, GRADU...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306800412·Metzenbaum Scissors, Straight, 14cm
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
S4C POLYAXIAL SCREW 3.5X12MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code MNI·May 1, 2009
DEPUY PINNACLE 300 ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC·Product code KWA·March 15, 2013
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
29G PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMI·May 23, 2008
Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code LRO·August 15, 2007
WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
FDA Enforcement
Class III
·Terminated·Copan Italia·September 11, 2013
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024