Panels › General Hospital › Product code KME · Class 1
Bedding, Disposable, Medical
Regulation 880.6060
0510(k)s in 12 months (65 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in KME
| Company | 510(k)s | Recalls |
|---|---|---|
| Sancella, Inc. | 4 | 0 |
| Anago, Inc. | 3 | 0 |
| Haz-Med, Inc. | 3 | 0 |
| Kimberly-Clark Corp. | 3 | 0 |
| Procter & Gamble Mfg. Co. | 3 | 0 |
| Abco Dealers, Inc. | 2 | 0 |
| American Threshold Industries, Inc. | 2 | 0 |
| Bio D Corp. | 2 | 0 |
| Biological & Environmental Control Laboratories | 2 | 0 |
| East Texas Lighthouse For the Blind | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2004 | K042145 | READY-HEAT BLANKET Techtrade, LLC | KME |
| Dec 2, 1994 | K944953 | OREX MEDICAL BEDDING Thantex Specialties, Inc. | KME |
| Jan 26, 1994 | K933636 | DISPOSE-A-SHEET Belmac Healthcare Corp. | KME |
| Nov 2, 1993 | K932539 | DOCTOR DOWN --RESCUE WRAP Three Dog Down | KME |
| Aug 10, 1992 | K922143 | AMERICAN BURN SHEET American Silk Sutures, Inc. | KME |
| Feb 20, 1992 | K915303 | FOIL BABY BUNTING Gam Industries, Inc. | KME |
| Dec 31, 1991 | K912257 | CHEM-SLEEVE B Haz-Med, Inc. | KME |
| May 28, 1991 | K911953 | MEDI GUARD SHEETS/UNDERLAYS Sancella, Inc., CA | KME |
| May 28, 1991 | K911952 | MEDI GUARD UNDERPAD Sancella, Inc., CA | KME |
| May 28, 1991 | K911948 | MEDI GUARD PILLOWCASE Sancella, Inc., CA | KME |
| May 21, 1991 | K911950 | MEDI GUARD DRAPES Sancella, Inc., CA | KME |
| Dec 28, 1990 | K905003 | BIO-GUARD SHAVE PREP TRAY Network Medical Systems, Inc. | KME |
| Oct 26, 1990 | K904274 | RECEIVING BLANKET Anago, Inc. | KME |
| Sep 12, 1990 | K901509 | TRAUMA SLEEVE Haz-Med, Inc. | KME |
| Apr 27, 1990 | K901629 | CHEM-SLEEVE Haz-Med, Inc. | KME |
| Apr 25, 1990 | K900643 | FLUID SOAKERSHIELD Infection Control Products, Inc. | KME |
| Jan 10, 1990 | K896043 | MATTRESS COVER FOR MEDICAL PURPOSES Keystone Veterinary Supplies, Inc. | KME |
| Dec 29, 1989 | K891986 | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE Mark One Healthcare Products | KME |
| Sep 7, 1989 | K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER Devon Industries, Inc. | KME |
| Nov 8, 1988 | K884380 | BED SHEET, PILLOW CASE Saybrex Intl., Inc. | KME |
| Jul 19, 1988 | K882332 | HEADREST, PATIENT COMFORT Surgic Aid, Inc. | KME |
| Jun 7, 1988 | K881969 | DRY COMFORT DISPOSABLE UNDERPAD Health Tec, Inc. | KME |
| Jun 3, 1988 | K881859 | DRIPRIDE DISPOSABLE UNDERPAD Weyerhaeuser Co. | KME |
| May 15, 1987 | K871725 | DRIPRIDE DISPOSABLE UNDERPADS Weyerhaeuser Co. | KME |
| Mar 17, 1987 | K870925 | PAD, BED LINEN PROTECTIVE Quality Disposables, Inc. | KME |
| Mar 13, 1987 | K870522 | DEPEND UNDERPAD Kimberly-Clark Corp. | KME |
| Mar 2, 1987 | K864158 | THERMAPAD Avail-Southwest Division | KME |
| Aug 27, 1986 | K863179 | KIMLON DISPOSABLE BLANKET Kimberly-Clark Corp. | KME |
| Jul 2, 1986 | K862348 | SINGLE-USE PATIENT UNDERPAD Procter & Gamble Mfg. Co. | KME |
| Feb 19, 1986 | K860066 | REFLECTIVE BLANKET O.R. Concepts, Inc. | KME |
| Nov 8, 1985 | K853970 | ALPHA CHUCK Rocky Mountain Medical Corp. | KME |
| Oct 16, 1985 | K853880 | ATTENDS DISPOS. UNDERPAD Procter & Gamble Mfg. Co. | KME |
| Apr 19, 1985 | K850067 | MEDICAL, DISPOSABLE BEDDING East Texas Lighthouse For the Blind | KME |
| Mar 21, 1985 | K850811 | PAD, PRE-OPERATIVE PREPARATION East Texas Lighthouse For the Blind | KME |
| Mar 12, 1985 | K850544 | SHAVE PREP TRAY Packaging Technologies, Inc. | KME |
| Dec 4, 1984 | K844196 | WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT Biological & Environmental Control Laboratories | KME |
| Dec 4, 1984 | K842989 | SHAVE PREP KITS Biological & Environmental Control Laboratories | KME |
| Oct 24, 1984 | K843038 | DISPOSABLE PATIENT BLANKET Anago, Inc. | KME |
| Sep 7, 1984 | K843402 | MOLINEA UNDERPADS Paul Hartmann Corp. | KME |
| Aug 1, 1984 | K842335 | PILLOW W/STAPHCHEK TICKING Monterey Mills, Inc. | KME |
| Jul 13, 1984 | K842336 | DISPOSABLE PILLOW Monterey Mills, Inc. | KME |
| Feb 13, 1984 | K832487 | DRAW SHEET, ANTI-MICROBIAL American Threshold Industries, Inc. | KME |
| Feb 13, 1984 | K832486 | PILLOW COVER, ANTI-MICROBIAL American Threshold Industries, Inc. | KME |
| Sep 30, 1982 | K822650 | SUPER DONUT Alimed, Inc. | KME |
| Jul 2, 1982 | K821835 | BARRIER BURN SHEET Uhi Corp. | KME |
| Mar 18, 1982 | K820582 | 3M THINSULATE DISPOSABLE HOSPITAL BED 3M Company | KME |
| Jan 5, 1982 | K813519 | NON-ABSORBENT TOWELS Cunningham Woodland, Inc. | KME |
| Nov 27, 1981 | K813263 | PATIENT UNDERPAD The Buckeye Cellulose Corp. | KME |
| Aug 4, 1981 | K812079 | DISPOSABLE PILLOW Carpenter Co. | KME |
| May 21, 1981 | K811232 | DISPOSABLE UNDERPADS Burina | KME |
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