Panels › General, Plastic Surgery › Product code KOZ · Class 1
Beads, Hydrophilic, For Wound Exudate Absorption
Regulation 878.4018
0510(k)s in 12 months (22 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KOZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew United, Inc. | 3 | 0 |
| Hollister, Inc. | 2 | 0 |
| Marion Laboratories, Inc. | 2 | 0 |
| Perstorp AB C/O Robert Joel Slomoff | 2 | 0 |
| Pharmaseal Laboratories | 2 | 0 |
| American Pharmaseal Div. Ahsc | 1 | 0 |
| Beiersdorf, Inc. | 1 | 0 |
| Bipore, Inc. | 1 | 0 |
| Coloplast A/S | 1 | 0 |
| Controlled Therapeutics Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 1991 | K905206 | INCARE PINSITE DRESSING Hollister, Inc. | KOZ |
| Apr 1, 1991 | K905688 | CUTINOVA HYDRO Beiersdorf, Inc. | KOZ |
| Jan 31, 1991 | K905069 | IODOSORB GEL Perstorp AB C/O Robert Joel Slomoff | KOZ |
| Jan 7, 1991 | K904604 | REDI-RELEASE ABSORBENT DRESSING Fountain Pharmaceuticals, Inc. | KOZ |
| Nov 21, 1990 | K903645 | DERMASORB WOUND CONTACT LAYER DRESSING Convatec, A Division of E.R. Squibb & Sons | KOZ |
| Nov 21, 1990 | K896828 | BIOCLUSIVE(R) ABSORBENT DRESSING Johnson & Johnson International | KOZ |
| Oct 23, 1990 | K904412 | ALLEVYN DRESSING CLAIMS CHANGE Smith & Nephew United, Inc. | KOZ |
| Jun 28, 1990 | K901876 | INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) Smith & Nephew United, Inc. | KOZ |
| Nov 24, 1989 | K896176 | EXUSORB(TM) DRY/WET DRESSING Controlled Therapeutics Corp. | KOZ |
| Nov 7, 1989 | K895354 | INTRASITE CAVITY WOUND DRESSING Smith & Nephew United, Inc. | KOZ |
| Jan 22, 1988 | K874552 | ENVISAN PAD Marion Laboratories, Inc. | KOZ |
| Jan 14, 1988 | K872453 | DEBRISAN ABSORBENT PAD Pharmacia, Inc. | KOZ |
| Dec 18, 1987 | K874553 | ENVISAN PASTE Marion Laboratories, Inc. | KOZ |
| Jul 24, 1987 | K872117 | DEXTRANOMER Interworld, Inc. | KOZ |
| Mar 27, 1987 | K870941 | PHARMASEAL WOUND CARE DRESSING PAD American Pharmaseal Div. Ahsc | KOZ |
| Mar 20, 1987 | K870559 | IODOSORB POWDER Perstorp AB C/O Robert Joel Slomoff | KOZ |
| Jan 16, 1985 | K844625 | BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY Bipore, Inc. | KOZ |
| Nov 8, 1984 | K834343 | COMFEEL POWDER Coloplast A/S | KOZ |
| Apr 21, 1982 | K820160 | HOLLISTER WOUND EXUDATE ABSORBER Hollister, Inc. | KOZ |
| Aug 4, 1980 | K800737 | DEBRISAN (DEXTRANOMER) PASTE Pharmaseal Laboratories | KOZ |
| Nov 30, 1978 | K780775 | MEDICAL PROTEIN HYDROLYSATE REVITAL Robertson Resources, Inc. | KOZ |
| Dec 16, 1976 | K760469 | CLEANSING AGENT, NEW WOUND (DEBRISSU) Pharmaseal Laboratories | KOZ |
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