Panels › General, Plastic Surgery › Product code FXX · Class 2
Mask, Surgical
Regulation 878.4040
7510(k)s in 12 months (607 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
Top companies in FXX
| Company | 510(k)s | Recalls |
|---|---|---|
| Tecnol New Jersey Wound Care, Inc. | 11 | 0 |
| Owens & Minor (O&M) Halyard, Inc. | 8 | 0 |
| Anago, Inc. | 7 | 0 |
| Protectaide, Inc. | 7 | 0 |
| 3M Company | 6 | 0 |
| Guangdong Kingfa Sci. & Tech.Co., Ltd. | 6 | 0 |
| AMD Medicom Inc. | 0 | 5 |
| Tecnol Medical Products, Inc. | 5 | 0 |
| Dukal Corp. | 4 | 0 |
| Kimberly-Clark | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 10, 1989 | K884877 | OCUSHIELDS MASKS Dioptics | FXX |
| Dec 15, 1988 | K884929 | OCCUSHIELDS Dioptics | FXX |
| Nov 18, 1988 | K884392 | KBM DENTAL MASK Kawamoto Bandage Material Co., Ltd., JP | FXX |
| Nov 17, 1988 | K883827 | MASKS, VARIOUS TYPES OF SURGICAL MASKS Greene International Corp., TW | FXX |
| Nov 14, 1988 | K883705 | FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS Select Sources, Inc. | FXX |
| Oct 25, 1988 | K883658 | I-SPOSE EYE SHIELD Products For Medicine | FXX |
| Oct 3, 1988 | K883828 | CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS Greene International Corp., TW | FXX |
| Sep 6, 1988 | K880534 | ZEPHYR Racal Health & Safety, Inc. | FXX |
| Aug 10, 1988 | K882883 | C-MASK(FLAT) Promedica Products, Inc. | FXX |
| Aug 10, 1988 | K882882 | C-MASK Promedica Products, Inc. | FXX |
| Jul 8, 1988 | K881913 | PROTECTO-SHIELD Syntech Mfg. Services | FXX |
| Jun 15, 1988 | K882028 | COVERALL SHIELD Bfd, Inc. | FXX |
| Jun 15, 1988 | K882027 | COMBO-SHIELD Bfd, Inc. | FXX |
| Jun 15, 1988 | K882026 | ADD-A-SHIELD Bfd, Inc. | FXX |
| May 18, 1988 | K881910 | LABELING CHANGE TO SURGICAL FACE MASK Louis M. Gerson Co., Inc. | FXX |
| May 9, 1988 | K881618 | ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 3M Company | FXX |
| Apr 8, 1988 | K881372 | ENDICOTT & BEAMAN SUPRA-TEC FACE MASK Endicott & Beaman, Inc. | FXX |
| Mar 28, 1988 | K874894 | TECNOL LASER SURGICAL MASK Tecnol New Jersey Wound Care, Inc. | FXX |
| Mar 11, 1988 | K880757 | TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD Tecnol New Jersey Wound Care, Inc. | FXX |
| Mar 11, 1988 | K875008 | GUARDALL SHIELD Anago, Inc. | FXX |
| Mar 4, 1988 | K880613 | ACCO(R) FACE MASK Absorbent Cotton Co., Inc. | FXX |
| Jan 22, 1988 | K875194 | KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001 Welch Allyn, Inc. | FXX |
| Jan 22, 1988 | K875172 | DISPOSABLE SURGICAL FACE MASK Irema USA , Ltd. | FXX |
| Jan 15, 1988 | K873731 | SAFETY SHIELD KIT Ballard Medical Products | FXX |
| Jan 7, 1988 | K874296 | INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER Ulti-Med Intl., Inc. | FXX |
| Dec 2, 1987 | K874608 | TECNOL FLUID SHIELD SURGICAL MASK Tecnol New Jersey Wound Care, Inc. | FXX |
| Nov 9, 1987 | K872935 | ANTI-INFECTION SHIELD Stackhouse Assoc. | FXX |
| Nov 2, 1987 | K873785 | TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE Tecnol New Jersey Wound Care, Inc. | FXX |
| Oct 5, 1987 | K873705 | CARERITE FACE MASK Cost Rite Health Products, Inc. | FXX |
| Jul 22, 1987 | K871558 | DENTAL FACE MASKS, POLYESTER Carl Parker Associates, Inc. | FXX |
| Feb 24, 1987 | K870312 | WHITE PLUME SURGICAL GAUZE FACE MASK China National Medicines & Health Prod. I/E Corp. | FXX |
| Feb 6, 1987 | K870056 | TECNOL CLASSIC CONE MASK Tecnol New Jersey Wound Care, Inc. | FXX |
| Apr 30, 1985 | K851556 | OP-FACE MASK(MASQUE DE CHIRUGIE) Roseburg SA | FXX |
| Feb 14, 1985 | K850247 | PERITONEAL DIALYSIS COIL CATHETER Sil-Med Corp. | FXX |
| Jul 17, 1984 | K831148 | HIGH FILTRATION ISO-MASK Tecnol New Jersey Wound Care, Inc. | FXX |
| Aug 12, 1983 | K832281 | TWO-PLY PAPER FACE FACE MASK Abco Dealers, Inc. | FXX |
| Jul 26, 1983 | K832194 | SURGICAL FACE MASK-DISPOSABLE Tecnol New Jersey Wound Care, Inc. | FXX |
| Apr 27, 1983 | K830890 | SURGICAL FACE MASK Busse Hospital Disposables, Inc. | FXX |
| Jan 7, 1983 | K823078 | SPUNGUARD FACE MASK Kimberly-Clark Corp. | FXX |
| Sep 17, 1982 | K822481 | MULTIPLE SURGICAL MASK Surgilite Intl., Inc. | FXX |
| Apr 14, 1982 | K820893 | DISPOSABLE SURGICAL FACE MASK Anago, Inc. | FXX |
| Dec 18, 1981 | K813078 | CONTURA DISPOS. SURG. FACE MASK American Convertors Div., American Pharmaseal | FXX |
| Dec 3, 1981 | K812997 | FILTER FLOW MASK CAT. #350 Eldredge Mfg. Co. | FXX |
| Dec 3, 1981 | K812996 | FILTER FLOW MASK CAT. #300 Eldredge Mfg. Co. | FXX |
| Dec 3, 1981 | K812992 | SURGICAL MASK South Mountain Medical | FXX |
| Oct 13, 1981 | K812675 | DISPOSABLE SURGICAL FACE MASKS Irema USA , Ltd. | FXX |
| Feb 23, 1981 | K810316 | SURGIKOS FACE MASK Surgikos, Inc. | FXX |
| Nov 12, 1980 | K802373 | SURGICAL FACE MASK Louis M. Gerson Co., Inc. | FXX |
| Jun 4, 1980 | K801036 | SURGICAL MASK American Threshold Industries, Inc. | FXX |
| Nov 5, 1979 | K792110 | CONPHAR FACE MASK-STERILE Conphar, Inc. | FXX |
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