Panels › Anesthesiology › Product code BSJ · Class 1
Mask, Gas, Anesthetic
Regulation 868.5550
0510(k)s in 12 months (51 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in BSJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Medipart Jerry Alexander | 6 | 0 |
| Engineered Medical Systems | 2 | 1 |
| Life Design Systems, Inc. | 3 | 0 |
| Vital Signs, Inc. | 3 | 0 |
| Hans Rudolph, Inc. | 2 | 0 |
| Ohio Medical Products | 2 | 0 |
| Rondex Products, Inc. | 2 | 0 |
| Warne Surgical Products, Ltd. | 2 | 0 |
| Advanced Warming Systems, Inc. | 1 | 0 |
| Ambu, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 13, 2017 | K163277 | SuperNO2VA Device Revolutionary Medical Devices, Inc. | BSJ |
| Aug 15, 1995 | K953107 | ANESTHESIA/RESPIRATORY FACE MASK Medical Marketing Concepts | BSJ |
| Aug 11, 1995 | K953295 | ANESTHESIA FACE MASK Mallinckrodt Medical | BSJ |
| Jul 11, 1995 | K952689 | BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK Owens-Brigam Medical Co. | BSJ |
| Jun 7, 1995 | K951043 | AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK Promedic, Inc. | BSJ |
| Mar 10, 1995 | K950771 | DISPOSABLE ADHESIVE FACE MASK Advanced Warming Systems, Inc. | BSJ |
| Jan 27, 1995 | K945894 | MASK, GAS, ANESTHETIC Hans Rudolph, Inc. | BSJ |
| Nov 8, 1994 | K945440 | DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK Fvtnks | BSJ |
| Oct 3, 1994 | K944157 | DISPOSABLE, PREFORMED FACE MASK Meridian Medical Systems, Inc. | BSJ |
| Aug 20, 1993 | K932147 | NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE Hans Rudolph, Inc. | BSJ |
| Jun 22, 1993 | K932014 | AMBU DISPOSABLE FACE MASK Ambu, Inc. | BSJ |
| Apr 8, 1992 | K915558 | IAS ANESTHESIA MASK Ias | BSJ |
| Sep 4, 1990 | K903881 | VENTLAB VENT-MASK, CAT# VR 0010/20/30 Ventlab Corp. | BSJ |
| Aug 22, 1990 | K902298 | ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS Rondex Products, Inc. | BSJ |
| Aug 21, 1989 | K891316 | ANESTHESIA/RESPIRATORY DISPOSABLE MASK Concord/Portex | BSJ |
| Aug 21, 1989 | K884157 | MODIFIED TOUCH-ME-NOT MASK Walt'S Products | BSJ |
| Apr 20, 1989 | K890795 | RESPIRONICS SEALEASY II Respironics, Inc. | BSJ |
| Jan 24, 1989 | K890108 | MODIFIED CUSHION-FLEX(TM) Life Design Systems, Inc. | BSJ |
| Nov 17, 1988 | K884387 | CUSHION FLEX(TM) Life Design Systems, Inc. | BSJ |
| Jun 30, 1988 | K882434 | MASK, GAS, ANESTHETIC Eastmed Enterprises, Inc. | BSJ |
| Apr 25, 1988 | K881393 | RONDEX RESCUE MASK Rondex Products, Inc. | BSJ |
| Mar 24, 1988 | K881067 | NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK Medesign, Inc. | BSJ |
| Mar 21, 1988 | K880682 | MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP King Systems Corp. | BSJ |
| Dec 21, 1987 | K874746 | SEALFLEX MASK Engineered Medical Systems | BSJ |
| Jun 17, 1987 | K872015 | SPIRASEAL(TM) FACE MASK (VARIOUS SIZES) Brigam, Inc. | BSJ |
| Jun 8, 1987 | K871851 | RIBBED CUSHION MASK Engineered Medical Systems | BSJ |
| Aug 1, 1986 | K862784 | MP-XMO DISPOSABLE FACE MASK Medipart Jerry Alexander | BSJ |
| Aug 1, 1986 | K862783 | MP-XMV DISPOSABLE FACE MASK Medipart Jerry Alexander | BSJ |
| Aug 1, 1986 | K862782 | MP-XML DISPOSABLE FACE MASK Medipart Jerry Alexander | BSJ |
| Aug 1, 1986 | K862781 | MP-XMM DISPOSABLE FACE MASK Medipart Jerry Alexander | BSJ |
| Apr 30, 1986 | K860686 | FACEGLOV,ANESTHETIC GAS MASK Loran , Ltd. | BSJ |
| Dec 3, 1985 | K853785 | SERIES 2000 MEDS MASK Med Systems | BSJ |
| Nov 5, 1985 | K854161 | SUR-FIT FACE MASK Anesthesia Respiratory Technology, Inc. | BSJ |
| Mar 25, 1985 | K850263 | PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY Plasmedics, Inc. | BSJ |
| Dec 4, 1984 | K844494 | MEDIPART FACE MASK MP-XM Medipart Jerry Alexander | BSJ |
| Dec 4, 1984 | K844493 | MEDIPART FACE MASK & FILTER MP-30XM Medipart Jerry Alexander | BSJ |
| Aug 20, 1984 | K843169 | CUSHION-FLEX TM Life Design Systems, Inc. | BSJ |
| Jul 6, 1984 | K842472 | DRYDEN INFLATABLE MASK Dryden Corp. | BSJ |
| Apr 5, 1984 | K841240 | DISPOSABLE ANESTHESIA MASK Hospitak, Inc. | BSJ |
| Feb 21, 1984 | K840535 | DISPOS. ANESTHESIA FACE MASK Marquest Medical Products, Inc. | BSJ |
| Feb 17, 1984 | K840452 | PREMIUM DABM DISPOS. ANES. BREATH MASK Ohio Medical Products | BSJ |
| Jan 25, 1984 | K834536 | CRYSTALCONE FACE MASK-MED-W/HOOKRING Warne Surgical Products, Ltd. | BSJ |
| Jan 18, 1984 | K834454 | PAEDIATRIC FACE MASK 1-3 W/WO RING Warne Surgical Products, Ltd. | BSJ |
| Jul 7, 1983 | K831713 | NON CONDUCTIVE ANESTHESIA FACEMASK Vital Signs, Inc. | BSJ |
| May 9, 1983 | K830982 | MASKS Medovations, Inc. | BSJ |
| Apr 26, 1982 | K821045 | NON CONDUCTIVE PEDIATRIC ANES. FACE Vital Signs, Inc. | BSJ |
| Apr 23, 1981 | K810990 | OHIO NONCONDUCTIVE RBS TYPE FACE MASK Ohio Medical Products | BSJ |
| Jan 5, 1981 | K803185 | NON-CONDUCTIVE ANESTHESIA FACE MASK Bd Becton Dickinson Vacutainer Systems Preanalytic | BSJ |
| Jun 4, 1980 | K801251 | NON-CONDUCTIVE, SINGLE USE FACE MASK #55 Vital Signs, Inc. | BSJ |
| May 25, 1979 | K790638 | ACCUTRON POLLUTION REDUCER Parker Laboratories, Inc. | BSJ |
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