HOLLISTER, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2320961	3003172243	HOLLISTER, INC.	1	Y	2026-01-01	12011 VOLUNTEER BLVD Mount Juliet TN US 37122

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
2725	1798539509	K992137	UROLOGICAL CATHETER	GBM	1999-09-03
2725	1265307125	K953232	HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE	KNT	1995-08-18
2725	1304260181	K932855	HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE	KNT	1993-10-13
2725	1778104110	K893888	HOLLISTER FEEDING TUBE ATTACHMENT DEVICE	KNT	1989-10-17
2725	1309391699	K862573	HOLLISTER DRAIN TUBE ATTACHMENT	KNT	1986-09-23
2725	1692958276	K213575	Female IC (Not Finalized)	EZD	2022-09-13
2725	1748543798	K211436	Intermittent Catheter (Not Finalized)	GBM	2022-01-27
2725	1415998758	K193148	VaPro Plus Pocket, VaPro Plus	GBM	2019-12-13
2725	1550197387	K183253	ValPro 2 Plus, VaPro 2 Plus Pocket	GBM	2018-12-18
2725	1358661712	K180824	VaPro 2 Intermittent Catheter	GBM	2018-06-22
2725	1689895899	K163179	Onli Intermittent Catheter	GBM	2017-01-26
2725	1465250946	K152268	VAPRO PLUS POCKET Intermittent Catheter	GBM	2015-09-09
2725	1416404380	K143594	VaPro Pocket	GBM	2015-01-09
2725	1696472706	K141642	VAPRO INTERMITTENT CATHETER	GBM	2014-08-22
2725	1086832626	K083153	ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007	KNT	2009-02-04
2725	1235976920	K040779	RESTORE WOUND CLEANSER	KMF	2004-05-17
2725	1945447266	K032710	CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT	KOD	2004-01-09
2725	1697462494	K013483	INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT	KOD	2002-01-14
2725	1741542895	K013345	INCARE INTERMITTENT CATHETER	KOD	2002-01-07
2725	1273702237	K011552	UROLOGICAL CATHETER	GBM	2001-07-18
2725	1155467556
2725	1155896324
2725	1240602801
2725	1255222799
2725	1308627748
2725	1432296328
2725	1466145503
2725	1472395612
2725	1479694550
2725	1504840906
2725	1551503658
2725	1551675110
2725	1650658691
2725	1667519951
2725	1678222350
2725	1762329970
2725	1816386135
2725	1835879549
2725	1851573452
2725	1886513583
2725	1894042832
2725	2071886547

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GBM	10	2022-01-27
KNT	5	2009-02-04
KOD	3	2004-01-09
EZD	1	2022-09-13
KMF	1	2004-05-17

PMN#

INSTAFLO BOWEL CATHETER SYSTEM KIT
2013-04-17
HOLLISTER, INC.
INSTAFLO BOWEL CATHETER SYSTEM KIT
2010-04-22
HOLLISTER, INC.
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
2009-08-20
HOLLISTER, INC.
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
2009-02-04
HOLLISTER, INC.
EVADRI BLADDER CONTROL SYSTEMS
2005-04-12
HOLLISTER, INC.
RESTORE WOUND CLEANSER
2004-05-17
HOLLISTER, INC.
INCARE PELVIC FLOOR THERAPY SYSTEM
2002-03-19
HOLLISTER, INC.
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
2002-03-05
HOLLISTER, INC.
INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT
2002-01-14
HOLLISTER, INC.
INCARE INTERMITTENT CATHETER
2002-01-07
HOLLISTER, INC.
MICROGYN PLUS STIMULATION DEVICE
2001-12-19
HOLLISTER, INC.
AMEDA HYGIENIKIT
2001-08-15
HOLLISTER, INC.
SIMPLICARE TRANSPARENT WOUND DRESSING
1999-10-14
HOLLISTER, INC.
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
1999-03-25
HOLLISTER, INC.
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
1998-08-21
HOLLISTER, INC.
SIMPLICARE THIN FILM WOUND DRESSINGS
1998-02-20
HOLLISTER, INC.
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
1997-12-23
HOLLISTER, INC.
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
1997-11-03
HOLLISTER, INC.
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
1997-06-25
HOLLISTER, INC.
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
1997-04-15
HOLLISTER, INC.
HOLLISTER RETRACTED PENIS POUCH
1997-02-25
HOLLISTER, INC.
INCARE HOT/ICE SYSTEM SHOULDER BLANKET
1996-12-31
HOLLISTER, INC.
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
1996-12-31
HOLLISTER, INC.
INCARE HOT/ICE LITE MACHINE
1996-11-27
HOLLISTER, INC.
HEELBO PELVIC RESTRAINT
1996-11-01
HOLLISTER, INC.
HEELBO JOHNNY GRAIT BELT SECURITY BELT
1996-10-24
HOLLISTER, INC.
CHECKMATE ANKLE RESTRAINT SYSTEM
1996-10-24
HOLLISTER, INC.
MICROGYN PLUS STIMULATION DEVICE
1996-10-23
HOLLISTER, INC.
HEELBO QUILTED TORSO RESTRAINT
1996-10-09
HOLLISTER, INC.
SELF RETAINING MALE EXTERNAL URINARY CATHETER
1996-09-16
HOLLISTER, INC.
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
1996-08-09
HOLLISTER, INC.
PERINEOMETER
1996-04-18
HOLLISTER, INC.
RECLOSABLE WOUND COVER
1995-10-23
HOLLISTER, INC.
INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
1995-10-17
HOLLISTER, INC.
HOLLISTER HYDROCOLLOID WOUND DRESSING
1995-10-06
HOLLISTER, INC.
EGNELL ELITE
1995-09-22
HOLLISTER, INC.
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
1995-08-18
HOLLISTER, INC.
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
1995-07-11
HOLLISTER, INC.
PREMIE U-BAG URINE SPECIMEN COLLECTOR
1995-02-07
HOLLISTER, INC.
INCARE HOT/ICE COLD THERAPY COOLER
1995-01-30
HOLLISTER, INC.

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