FDA 510(k) Applications Submitted by MARK HELLER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K141286 |
05/16/2014 |
AER-O-SCOPE COLONOSCOPE SYSTEM |
GI VIEW LTD. |
| K955792 |
12/22/1995 |
WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND, SAFETY W/OUT LOCK, SET OF SUCTION - IRRIGA0 |
WILO MEDIZINTECHNIK LOTHAR WILBERG GMBH |
| K960342 |
01/24/1996 |
POS-T-VAC AVP-1000 & MVP-700 |
POS-T-VAC, INC. |
| K960828 |
02/29/1996 |
POS-T-VAC B-10 BAND KIT |
POS-T-VAC, INC. |
| K981011 |
03/18/1998 |
POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) |
POS-T-VAC, INC. |
| K981180 |
04/01/1998 |
REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT |
POS-T-VAC, INC. |
| K961309 |
04/04/1996 |
POS-T-VAC ID-300 |
POS-T-VAC, INC. |
| K050869 |
04/06/2005 |
MODIFICATION TO ABL800 FLEX |
RADIOMETER MEDICAL APS |
| DEN130036 |
07/15/2013 |
PROSTATE IMMOBILIZER RECTAL BALLOON |
RADIADYNE |
| K962903 |
07/25/1996 |
PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE |
PRESTIGE MEDICAL CORP. |
| K124041 |
12/28/2012 |
NBM-200MP |
ORSENSE LTD |
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