FDA 510(k) Applications Submitted by JEFFREY R SHIDEMAN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990039 |
01/06/1999 |
GAMBRO DQM 200 |
GAMBRO HEALTHCARE |
| K980386 |
02/02/1998 |
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) |
GAMBRO HEALTHCARE |
| K060346 |
02/10/2006 |
ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM |
ULTRAZONIX DNT AB |
| K010667 |
03/06/2001 |
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R |
GAMBRO RENAL PRODUCTS |
| K981003 |
03/18/1998 |
ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
| K120831 |
03/19/2012 |
ANCHORSURE |
NEOMEDIC INTERNATIONAL S.L. |
| K951311 |
03/22/1995 |
GAMBRO HC 14R HEMOCONCENTRATOR |
COBE RENAL CARE, INC. |
| K971053 |
03/24/1997 |
ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
| K010985 |
04/02/2001 |
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L |
GAMBRO RENAL PRODUCTS |
| K982413 |
07/13/1998 |
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS |
GAMBRO HEALTHCARE |
| K982414 |
07/13/1998 |
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS |
GAMBRO HEALTHCARE |
| K051951 |
07/18/2005 |
CERAMENT BONE VOID FILLER |
BONE SUPPORT AB |
| K052125 |
08/05/2005 |
CARBONAID GAS DIFFUSER |
CARDIA INNOVATION AB |
| K062341 |
08/10/2006 |
MALE REMEEX SYSTEM |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
| K982818 |
08/11/1998 |
HOSPAL TIPSTOP |
GAMBRO HEALTHCARE |
| K973253 |
08/29/1997 |
ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
| K944436 |
09/12/1994 |
COBE CENTRYSYSTEM CS 200 DIALYZER |
COBE RENAL CARE, INC. |
| K102815 |
09/28/2010 |
SURELIFT PROLAPSE SYSTEM |
NEOMEDIC INTERNATIONAL |
| K112975 |
10/05/2011 |
CARBONAID C02 DIFFUSER |
CARDIA INNOVATION AB |
| K103022 |
10/12/2010 |
KIM |
NEOMEDIC INTERNATIONAL S.L. |
| K033310 |
10/14/2003 |
REMEEX SYSTEM FOR URINARY INCONTINENCE |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
| K983618 |
10/15/1998 |
DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
| K063136 |
10/16/2006 |
NEEDLELESS SLING |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
| K063183 |
10/19/2006 |
PRISMA M10 PRE SET |
GAMBRO RENAL PRODUCTS, INC. |
| K023615 |
10/28/2002 |
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR |
GAMBRO RENAL PRODUCTS |
| K955487 |
12/01/1995 |
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS |
COBE RENAL CARE, INC. |
| K955497 |
12/01/1995 |
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET |
COBE RENAL CARE, INC. |
| K994390 |
12/28/1999 |
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER |
GAMBRO HEALTHCARE |
| K974899 |
12/30/1997 |
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H |
GAMBRO HEALTHCARE |
| K962427 |
06/24/1996 |
COBE CENTRYSYSTEM 700 HG HEMODIALYZER |
GAMBRO HEALTHCARE |
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