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 |
|---|---|---|---|
| Apr 29, 1994 | K932133 | EYSOTEK Isotech Corp. | FXX |
| Apr 29, 1994 | K932132 | EYSOTEK Isotech Corp. | FXX |
| Apr 15, 1994 | K932137 | FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR Tecnol Medical Products, Inc. | FXX |
| Apr 13, 1994 | K934974 | FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD Mid America Medical, Inc. | FXX |
| Mar 28, 1994 | K934969 | DUALGARD FACE SHIELD White Knight Healthcare | FXX |
| Mar 28, 1994 | K934194 | BARRIER LASER PLUS FACE MASK Johnson & Johnson Medical, Inc. | FXX |
| Feb 10, 1994 | K920108 | BARRIER EXTRA PROTECTION PLUS FACE MASK Johnson & Johnson Medical, Inc. | FXX |
| Feb 3, 1994 | K925185 | ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS Louis M. Gerson Co., Inc. | FXX |
| Nov 30, 1993 | K930067 | BUFFALO FILTER SURGICAL MASK Buffalo Filter Co., Inc. | FXX |
| Jan 27, 1993 | K920162 | TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK Tecnol Medical Products, Inc. | FXX |
| Jan 27, 1993 | K915817 | TECNOL FLUIDSHIELD INFECTION CONTROL MASK Tecnol Medical Products, Inc. | FXX |
| Nov 16, 1992 | K922507 | GERSON ISOLAIR APR PARTICULATE SURGICAL MASK Louis M. Gerson Co., Inc. | FXX |
| Oct 23, 1992 | K922716 | SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509 Splash Shield, Inc. | FXX |
| Oct 5, 1992 | K920203 | TECNOL INFECTION CONTROL MASK Tecnol Medical Products, Inc. | FXX |
| Sep 1, 1992 | K920846 | CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER Trinity Laboratories, Inc. | FXX |
| Apr 28, 1992 | K920682 | PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001 Phoenix Steri-Tech, Inc. | FXX |
| Feb 14, 1992 | K914832 | SURGICAL APPAREL W. L. Gore & Associates, Inc. | FXX |
| Dec 19, 1991 | K914412 | MASK, SURGICAL, DISPOSABLE Industries For the Blind | FXX |
| Nov 7, 1991 | K913558 | RELIABLE CONE STYLE FACE MASK Anago, Inc. | FXX |
| Aug 29, 1991 | K911334 | MASK, SURGICAL APPAREL Thai Hospital Products Co., Ltd., TH | FXX |
| Aug 23, 1991 | K913043 | MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS Tecnol New Jersey Wound Care, Inc. | FXX |
| Jul 12, 1991 | K911891 | FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK Tecnol New Jersey Wound Care, Inc. | FXX |
| Jul 8, 1991 | K911907 | FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS Tecnol New Jersey Wound Care, Inc. | FXX |
| Apr 29, 1991 | K910557 | BARRIER* EXTRA PROTECTION PLUS FACE MASK Johnson & Johnson Medical, Inc. | FXX |
| Mar 20, 1991 | K910110 | TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK 3M Company | FXX |
| Mar 6, 1991 | K905865 | ANTI-FOR SURGICAL FACE MASK Anago, Inc. | FXX |
| Mar 4, 1991 | K910182 | 3M BRAND EAR LOOP FACE MASK, 2000F 3M Company | FXX |
| Mar 4, 1991 | K905749 | SURGICAL FACE MASK Anago, Inc. | FXX |
| Feb 21, 1991 | K905209 | SURGICAL MASK Lancaster County Blind Assoc. | FXX |
| Oct 23, 1990 | K903486 | MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493 Pennsylvania Association For the Blind | FXX |
| Sep 5, 1990 | K902547 | THE PROTECTOR II, LASER SURGICAL MASK Anago, Inc. | FXX |
| Sep 5, 1990 | K902546 | THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK Anago, Inc. | FXX |
| May 14, 1990 | K900665 | DRESSING CHANGE KIT Healthdyne Cardiovascular, Inc. | FXX |
| Mar 8, 1990 | K900088 | MASKS SURGICAL DENTAL Kab Gloves Unltd. | FXX |
| Feb 27, 1990 | K896193 | TECNOL LAZER(TM) SURGICAL MASK Tecnol New Jersey Wound Care, Inc. | FXX |
| Nov 3, 1989 | K895077 | SURGICAL MASK/DENTAL MASK Ashton Medical Products, Inc. | FXX |
| Sep 12, 1989 | K894905 | FACE PROTECTION PAK(TM) Protech Products | FXX |
| Sep 12, 1989 | K894516 | VISOSHIELD(TM), SURGICAL EYE PROTECTOR Polamedco, Inc. | FXX |
| Jul 14, 1989 | K893939 | ISOLATION MASKS James River Corp. | FXX |
| Jun 23, 1989 | K893634 | MODIFIED STERILIZATION OF TUR APRONS Brant-Wald Surgicals, Inc. | FXX |
| Jun 22, 1989 | K893417 | SURGIFRESH SUB-MICRON MASK NO. 901008-000 Texas Medical Products, Inc. | FXX |
| May 15, 1989 | K892451 | SAFE-T-FACE DISPOSABLE FACE SHIELD Barry S. Smith Co. | FXX |
| Apr 18, 1989 | K891141 | CARERITE FACE MASK Cost Rite Health Products, Inc. | FXX |
| Apr 12, 1989 | K891056 | SURGICAL CONE MASK Dispomed, Inc. | FXX |
| Apr 12, 1989 | K891052 | SPLASH GUARD GOGGLE Dispomed, Inc. | FXX |
| Apr 12, 1989 | K891051 | SURGICAL FACE MASK-EAR LOOP Dispomed, Inc. | FXX |
| Apr 7, 1989 | K891409 | PRECEPT MICRO-GARD LASER MASK Mars White Knight | FXX |
| Mar 14, 1989 | K890771 | ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK 3M Company | FXX |
| Feb 14, 1989 | K890128 | FACELOCK FILTER MASK Alpha Protech, Inc. | FXX |
| Feb 3, 1989 | K890016 | FACE MASK Anjudd Intl. | FXX |
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