Scican Ltd.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
21
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2285-2023Class IISTATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care providerJune 22, 2023
Z-2286-2023Class IISTATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care providerJune 22, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K214057STATIM 6000B Vacuum AutoclaveMarch 31, 2022
K210326Bravo G4 Chamber AutoclaveJuly 1, 2021
K192910STATClave G4 Chamber AutoclaveJune 19, 2020
K190062STATCLAVE G4 Chamber AutoclaveJuly 26, 2019
K172292SALUS - Hygiene Instrument Reprocessing ContainerNovember 24, 2017
K132356SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40STJanuary 31, 2014
K112872STATIM 2000 G4 CASSETTEJuly 10, 2012
K090937E-STATIS 40 SYSTEMJuly 24, 2009
K090265BRAVO AUTOCLAVE, MODELS 17, 17V AND 21VMay 15, 2009
K073319STATMATIC 31 HANDPIECE MAINTENANCE UNITFebruary 4, 2008
K072466STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101December 19, 2007
K071891STATIS DENTAL HANDPIECESSeptember 13, 2007
K062418K-SPRAY, MODEL 085-2715October 19, 2006
K021064QUANTIM 16 AUTOCLAVEAugust 8, 2002
K983679STATIM 5000 CASSETTE AUTOCLAVEJanuary 4, 1999
K964691TCB TEMPORARY CROWN AND BRIDGE MATERIALFebruary 4, 1997
K962179STAT IM 5000 CASSETTE AUTOCLAVEJanuary 13, 1997
K944036STERIMASTER AUTOCLAVEOctober 2, 1996
K945142POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)January 11, 1995
K915054STATIM CASSETT AUTOCLAVE, MODIFICATIONAugust 4, 1992