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 |
|---|---|---|---|
| Aug 23, 1999 | K991559 | MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD Medline Industries, Inc. | FXX |
| Jul 12, 1999 | K990719 | EARLOOP FACE MASK Shuenn Bao Shing Corp., TW | FXX |
| Apr 9, 1999 | K984389 | TOP WHOLESOME FACE MASK Top Wholesome Enterprise Co., Ltd., TH | FXX |
| May 28, 1998 | K972849 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) Cypress Medical Products, Ltd. | FXX |
| Feb 26, 1998 | K972883 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) Cypress Medical Products, Ltd. | FXX |
| Sep 3, 1997 | K970835 | FACE MASK, SURGICAL MASK, NON-STERILE Tucker & Associates | FXX |
| Jul 28, 1997 | K971744 | FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) Berkley Medical Resources, Inc. | FXX |
| Jun 27, 1997 | K971130 | DEFEND FLUID RESISTANT PLEATED MASK Carl Parker Associates, Inc. | FXX |
| May 6, 1997 | K964114 | DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS Depuy, Inc. | FXX |
| Mar 27, 1997 | K970440 | EKONIC DENTAL/MEDICAL MASK (MD 610) Ekonic Company, Ltd. | FXX |
| Mar 11, 1997 | K965107 | MEDLINE ADMISSION KITS Medline Industries, Inc. | FXX |
| Mar 10, 1997 | K965043 | 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE Minnesota Mining and Mfg. Co. | FXX |
| Mar 3, 1997 | K964168 | PROCEDURE SPECIFIC KITS Sage Products, Inc. | FXX |
| Feb 25, 1997 | K963568 | MASK SURGICAL The Innovative Approach, Corp. | FXX |
| Feb 14, 1997 | K964358 | AMSEAL SURGICAL FACE MASK American Seal Co. | FXX |
| Feb 7, 1997 | K964723 | RACAL N95 RESIRATOR Racal Filter Technologies, Inc., CA | FXX |
| Feb 7, 1997 | K964722 | DELTA N95 RESPIRATOR Racal Filter Technologies, Inc., CA | FXX |
| Jan 27, 1997 | K962654 | COMPLEAT SURGICAL MASK Carl Parker Associates, Inc. | FXX |
| Jan 3, 1997 | K962443 | N95 FILTERING FACEPIECE Survivair, Inc. | FXX |
| Oct 7, 1996 | K962286 | 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD Berkley Medical Resources, Inc. | FXX |
| Jul 25, 1996 | K961217 | BODILY FLUID DISPOSAL KIT Transidyne General Corp. | FXX |
| Jul 12, 1996 | K961402 | STS SHIELD WITH MASK Innovative Outsourcing Solutions | FXX |
| Jul 12, 1996 | K960048 | EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS Safetec of America, Inc. | FXX |
| May 1, 1996 | K955382 | 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 3M Company | FXX |
| Apr 25, 1996 | K955557 | FLUID REISISTANT EYESHIELD MASK American Threshold Healthcare | FXX |
| Apr 25, 1996 | K955556 | FLUID RESISTANT MASK American Threshold Healthcare | FXX |
| Apr 22, 1996 | K955513 | SURGICAL MASK (NON-STERILE) United Medical Ent., Inc. | FXX |
| Jan 26, 1996 | K953754 | GLOBAL HEALTHCARE FACE MASK Global Healthcare, Inc. | FXX |
| Jan 23, 1996 | K952961 | BODY FLUID BARRIER KIT Lhb Industries, Inc. | FXX |
| Dec 11, 1995 | K953102 | BLOODBORNE PATHOGEN KIT Certified Safety Mfg., Inc. | FXX |
| Oct 12, 1995 | K951913 | OVAL SURGICAL FACE MASK Oval Industries, Ltd. | FXX |
| Sep 27, 1995 | K952962 | EZ-PERSONAL PROTECTION KIT Safetec of America, Inc. | FXX |
| Jun 28, 1995 | K950554 | NORTH BLOODBORNE PATHOGEN RESPONSE KIT North Safety Products | FXX |
| Jun 9, 1995 | K946001 | EMERGENCY RESPONSE SAFETY KIT Ani Safety, Inc. | FXX |
| Jun 2, 1995 | K933683 | PENTAX FACE MASK Pentax Precision Instrument Corp. | FXX |
| Mar 22, 1995 | K946343 | INTEC EXTENDED EYE SHIELD WITH MASK Intec Industries, Inc. | FXX |
| Dec 15, 1994 | K944880 | BODILY FLUID DISPOSAL KIT Clinical Resources, Inc. | FXX |
| Nov 2, 1994 | K944545 | BODY FLUIDS BARRIER KIT Ani Safety, Inc. | FXX |
| Nov 2, 1994 | K940720 | BUSSE ISOLATION AND PROCEDURAL MASKS Busse Hospital Disposables, Inc. | FXX |
| Oct 18, 1994 | K942476 | PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069 Protectaide, Inc. | FXX |
| Oct 18, 1994 | K942475 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351 Protectaide, Inc. | FXX |
| Oct 18, 1994 | K942474 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 Protectaide, Inc. | FXX |
| Oct 18, 1994 | K942473 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592 Protectaide, Inc. | FXX |
| Oct 18, 1994 | K942472 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123 Protectaide, Inc. | FXX |
| Oct 18, 1994 | K942471 | PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777 Protectaide, Inc. | FXX |
| Oct 18, 1994 | K942470 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315 Protectaide, Inc. | FXX |
| Jun 17, 1994 | K933748 | SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD Bam Corp., Ltd., HK | FXX |
| May 23, 1994 | K940707 | 3M SURGICAL MASK WITH FACE SHEILD 3M Company | FXX |
| May 3, 1994 | K932834 | TECNOL PCM 2000 Tecnol Medical Products, Inc. | FXX |
| May 2, 1994 | K931580 | DISPOSABLE SURGICAL MASK (MODIFIED) Bam Corp., Ltd., HK | FXX |
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