Hollister, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
85
Inspections
4
Compliance Actions
0

Known Names

hollister, hollister incorporated

Recent 510(k) Clearances

K-NumberDeviceDate
K123804INSTAFLO BOWEL CATHETER SYSTEM KITApril 17, 2013
K100273INSTAFLO BOWEL CATHETER SYSTEM KITApril 22, 2010
K090960VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,7214August 20, 2009
K083153ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007February 4, 2009
K050483EVADRI BLADDER CONTROL SYSTEMSApril 12, 2005
K040779RESTORE WOUND CLEANSERMay 17, 2004
K013612INCARE PELVIC FLOOR THERAPY SYSTEMMarch 19, 2002
K013653INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBEMarch 5, 2002
K013483INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KITJanuary 14, 2002
K013345INCARE INTERMITTENT CATHETERJanuary 7, 2002
K013141MICROGYN PLUS STIMULATION DEVICEDecember 19, 2001
K011519AMEDA HYGIENIKITAugust 15, 2001
K991214SIMPLICARE TRANSPARENT WOUND DRESSINGOctober 14, 1999
K990456ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOPMarch 25, 1999
K980976AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAPAugust 21, 1998
K980209SIMPLICARE THIN FILM WOUND DRESSINGSFebruary 20, 1998
K974048INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTERDecember 23, 1997
K973023INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKETNovember 3, 1997
K971541VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPONJune 25, 1997
K970602VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALLApril 15, 1997