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Holter-Hausner Intl.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
42
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K875287H-H FLUSHING RESERVOIRJuly 14, 1988
K874508H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAGJanuary 19, 1988
K872293H-H HUNTER ACTIVE TENDON IMPLANT BCSeptember 28, 1987
K872285H-H HUNTER ACTIVE TENDON IMPLANT DCSeptember 28, 1987
K872284H-H HUNTER ACTIVE TENDON IMPLANT PCSeptember 28, 1987
K871351H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAPMay 14, 1987
K870660H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMSMay 1, 1987
K865075H-H SUBGALEAL TROCARJanuary 13, 1987
K853437H-H HUNTER TENDON RODOctober 16, 1985
K853436H-H HUNTER PASSIVE TENDON IMPLANTOctober 16, 1985
K853438H-H HUNTER ACTIVE TENDON IMPLANTSeptember 30, 1985
K853370H-H CATHETER PASSERS(TACL DESIGNSeptember 18, 1985
K853371H-H ATRIAL CATHETERS & PERITONEAL CATHETERSSeptember 18, 1985
K853369H-H FIXATION & JOINING CONNECTORSSeptember 11, 1985
K853367H-H BURR HOLE CATHETER SUPPORTSeptember 11, 1985
K853366H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNTSeptember 11, 1985
K853368H-H SHUNT INTRODUCERSeptember 6, 1985
K853365H-H FIFTH VENTRICLESeptember 5, 1985
K853364H-H RICKHAM TYPE RESERVOIRSeptember 5, 1985
K853363H-H CRUCIFORM-SLIT VALVESeptember 3, 1985