Bio-Med Devices, Inc.
Guilford, CT, US
BIO-MED DEVICES, INC. appears in FDA device records in Guilford, CT. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Bio-Med Devices, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Biomed Devices Corp.510(k), recall
510(k) clearance history
FDA records hold 16 510(k) clearances for Bio-Med Devices, Inc. between 1980 and 2022. The busiest year on record is 1987, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 1 |
| 1983 | 2 |
| 1987 | 3 |
| 1988 | 1 |
| 1990 | 2 |
| 1995 | 1 |
| 1997 | 2 |
| 2018 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213948 | OxyMinder | CCL | Substantially Equivalent | |
| K173973 | TV-100 | CBK | Substantially Equivalent | |
| K971515 | PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK) | LPL | Substantially Equivalent | |
| K970615 | PROMED 55-G SOFT DAILY WEAR CONTACT LENS | LPL | Substantially Equivalent | |
| K942938 | CROSSVENT-4 VENTILATOR | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K896381 | MVP-10 MRI INFANT VENTILATOR | CBK | Substantially Equivalent | |
| K896380 | IC-2A MRI ADULT/PEDIATRIC VENTILATOR | CBK | Substantially Equivalent | |
| K873614 | CBG CUFF MANOMETER | BSK | Substantially Equivalent | |
| K871337 | M-2 OXYGEN/TEMPERATURE MONITOR | CCL | Substantially Equivalent | |
| K871336 | M-1 PRESSURE MONITOR | CAP | Substantially Equivalent | |
| K871139 | M-10 VENTILATION MONITOR | CAP | Substantially Equivalent | |
| K830230 | PROGRAMMABLE VENTILATOR | CBK | Substantially Equivalent | |
| K823861 | ET-3 EMERGENCY TRANSPORT VENTILATOR | CBK | Substantially Equivalent | |
| K813253 | IC-5 VENTILATOR | CBK | Substantially Equivalent | |
| K801890 | IC-2 VENTILATOR | CBK | Substantially Equivalent | |
| K800125 | VENTILATOR TEST LUNG | CBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1218704 | 3003952420 | BIO-MED DEVICES, INC. | 61 SOUNDVIEW RD, GUILFORD, CT 06437 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BSKCuff, Tracheal Tube, Inflatable
- LPLLenses, Soft Contact, Daily Wear
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BZOSet, Tubing And Support, Ventilator (W Harness)
- CBKVentilator, Continuous, Facility Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0972-2011 | Bio Med Devices Disposable Pediatric Breathing Circuit, One Set Catalog Number: 4040LC 5 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilators | Breathing circuit may disconnect between the adapter adjacent tubing cuff | Terminated | ||
| Z-0971-2011 | Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number: 4040LC-9 9 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilator | Breathing circuit may disconnect between the adapter adjacent tubing cuff | Terminated | ||
| Z-0430-05 | Bio-Med Dental Breathing Circuit Product NUmber: DENTL | Adapters may be occluded potentially preventing inhalation | Terminated | ||
| Z-0429-05 | Bio-Med Patient Breathing Circuit Product NUmber: 3030-5 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 3030-5 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-PRESSURE GAGE LINE 1/8''IDx72'' 1-PATIENT HOSE 22mmIDx6'' 1-EXHALATION VALVE w/COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE 1/8''IDx72 2-ADAPTERS 22mmx22mm | Adapters may be occluded potentially preventing inhalation | Terminated | ||
| Z-0428-05 | Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60'' 2- TUBING FITTINGS 1- 22x22mm ADAPTER | Adapters may be occluded potentially preventing inhalation | Terminated | ||
| Z-0427-05 | Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-9 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A-9 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx108'' 1-PATIENT HOSE 22mmIDx36'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 1-EXHALATION VALVE w/HOLDING ARM&COLLECTION HEAD 102'' w/CUFF 1/4''ID 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm | Adapters may be occluded potentially preventing inhalation | Terminated | ||
| Z-0426-05 | Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx90'' 1-PATIENT HOSE 22mmIDx18'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 84'' w/CUFF 1/4''ID 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm | Adapters may be occluded potentially preventing inhalation | Terminated | ||
| Z-0425-05 | Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 1-PATIENT HOSE 22mmIDx6'' 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 48'' w/CUFF 1/4''ID 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE 1/8''IDx48'' 2-ADAPTERS 22mmx22mm | Adapters may be occluded potentially preventing inhalation | Terminated | ||
| Z-0424-05 | Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT SMOOTH BORE HOSE 1-ADAPTER 22mmx22mm 22mmIDx72'' w/CLIPS 1-ADULT PRESSURE TEE w/.140 HOLE 1-LINE 1/8''IDx84'' 1-TEE 1/8''x1/8''x1/8'' 1-LINE 1/8''IDx24'' 1-HOLDING ARM 1-LINE 1/8''IDx2'' 1-CUFF 1/4''IDx2'' | Adapters may be occluded potentially preventing inhalation | Terminated | ||
| Z-0423-05 | Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' 1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM& 1-TEMPERATURE ADAPTER 22mmID x 22mm COLLECTION HEAD 2-CUFF 1/4''ID x 5/4'' 1-EXHALATION VALVE LINE 1/8''IDx52'' | Adapters may be occluded potentially preventing inhalation | Terminated | ||
| Z-0300-04 | MVP-10 Pediatric/ Neonatal Volume Ventilator | Two way relief valve may fail to activate at the low negative pressure of -3cm H2O. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain