Company ยท US
Bio-Med Devices, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2022. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 2022 | K213948 | OxyMinder Bio-Med Devices, Inc. | CCL |
| Jul 20, 2018 | K173973 | TV-100 Bio-Med Devices, Inc. | CBK |
| Sep 19, 1995 | K942938 | CROSSVENT-4 VENTILATOR Bio-Med Devices, Inc. | CBK |
| Feb 12, 1990 | K896381 | MVP-10 MRI INFANT VENTILATOR Bio-Med Devices, Inc. | CBK |
| Feb 12, 1990 | K896380 | IC-2A MRI ADULT/PEDIATRIC VENTILATOR Bio-Med Devices, Inc. | CBK |
| Jan 22, 1988 | K873614 | CBG CUFF MANOMETER Bio-Med Devices, Inc. | BSK |
| Jun 5, 1987 | K871337 | M-2 OXYGEN/TEMPERATURE MONITOR Bio-Med Devices, Inc. | CCL |
| Jun 5, 1987 | K871336 | M-1 PRESSURE MONITOR Bio-Med Devices, Inc. | CAP |
| Apr 21, 1987 | K871139 | M-10 VENTILATION MONITOR Bio-Med Devices, Inc. | CAP |
| Feb 9, 1983 | K830230 | PROGRAMMABLE VENTILATOR Bio-Med Devices, Inc. | CBK |
| Feb 7, 1983 | K823861 | ET-3 EMERGENCY TRANSPORT VENTILATOR Bio-Med Devices, Inc. | CBK |
| Dec 9, 1981 | K813253 | IC-5 VENTILATOR Bio-Med Devices, Inc. | CBK |
| Nov 18, 1980 | K801890 | IC-2 VENTILATOR Bio-Med Devices, Inc. | CBK |
| Jan 24, 1980 | K800125 | VENTILATOR TEST LUNG Bio-Med Devices, Inc. | CBK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio-Med Dental Breathing Circuit
Product NUmber: DENTL Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio-Med Patient Breathing Circuit
Product NUmber: 3030-5
Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 3030-5
PATIENT BREATHING CIRCUIT
=-=-=-=-=-=-=-= Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Pneumotach, Disposable (B)
Catalog Number: 4408
Labeled in part:
SINGLE USE CATALOG NO.4408
PNEUMOTACH, DISPOSABLE (B)
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=- Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A-9
Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 8002A-9
PATIENT BREATHING CIRCUIT
=-=-=- Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A-7
Labeled in part:
ONE SET - SINGLE USE ATALOG NO. 8002A-7
PATIENT BREATHING CIRCUIT
=-=-= Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A
Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 8002A
PATIENT BREATHING CIRCUIT
=-=-=- Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 80015
Labeled in part:
DO NOT REUSE DISPOSABLE
DISPOSABLE PATIENT BREATHING CIRCUIT
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=
CONTENT Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 80011
Labeled in part: '':PATIENT BREATHING CIRCUIT
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42 Terminated |
CBK | None listed |
| Jan 6, 2004 | Bio-Med Devices, Inc. MVP-10 Pediatric/ Neonatal Volume Ventilator Terminated |
MNT | None listed |