Bear Medical Systems, Inc.
Mchenry, IL, US
Bear Medical Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Bear Medical Systems, Inc. between 1982 and 1999. The busiest year on record is 1984, with 7. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 7 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 6 |
| 1988 | 3 |
| 1989 | 2 |
| 1990 | 2 |
| 1992 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992788 | BEAR CUB 750 PSV | CBK | Substantially Equivalent | |
| K983981 | BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE | CBK | Substantially Equivalent | |
| K912619 | BEAR 7 VENTILATOR | CBK | Substantially Equivalent | |
| K900637 | BEAR CEM CONTROLLER | CBK | Substantially Equivalent | |
| K896315 | BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY | BTT | Substantially Equivalent | |
| K893034 | VHS 820 HUMIDIFIER, MODIFICATION | BTT | Substantially Equivalent | |
| K890724 | MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR | BZK | Substantially Equivalent | |
| K882764 | BEAR EVC-100 CONTROLLER | CBK | Substantially Equivalent | |
| K881335 | BEAR 3 VENTILATOR | CBK | Substantially Equivalent | |
| K872660 | BEAR NVM-1 | BZK | Substantially Equivalent | |
| K873634 | BEAR VH-820 HUMIDIFIER | BTT | Substantially Equivalent | |
| K871985 | BEAR JET VENTILATOR FOR USE DURING (ESWL) | CBK | Substantially Equivalent | |
| K864589 | TRI-SERVICE OMV VAPORIZER | BSZ | Substantially Equivalent | |
| K864590 | AM1000 | BSZ | Substantially Equivalent | |
| K864605 | VAPLOK | CAD | Substantially Equivalent | |
| K864588 | PENLON CIRCLE SYSTEM | CAI | Substantially Equivalent | |
| K860692 | PTR MK II VENTILATOR | BYT | Substantially Equivalent | |
| K853346 | BEAR NICU-1 | BZK | Substantially Equivalent | |
| K850795 | AIR COMPRESSOR | BTI | Substantially Equivalent | |
| K842688 | BEAR JET-150 VENTILATOR | CBK | Substantially Equivalent | |
| K842340 | VH820 HUMIDIFIER | BTT | Substantially Equivalent | |
| K842363 | PENLON ANESTHESIA VENTILATOR SERIES 300 | CBK | Substantially Equivalent | |
| K842362 | PENLON TRANSPORT VENTILATOR SERIES 350 | CBK | Substantially Equivalent | |
| K841279 | BEAR 33 | CBK | Substantially Equivalent | |
| K840119 | CONTINUOUS VENTILATOR | CBK | Substantially Equivalent | |
| K834555 | BEAR VENTI--VOICE | ESE | Substantially Equivalent | |
| K830165 | BEAR JET 150 VENTILATOR | FLI | Substantially Equivalent | |
| K822912 | BEAR VM-90 VENTILATION MONITOR | BZK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FLICabinet, Ethylene-Oxide Gas Aerator
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BTICompressor, Air, Portable
- BSZGas-Machine, Anesthesia
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- ESELarynx, Artificial (Battery-Powered)
- BZKSpirometer, Monitoring (W/Wo Alarm)
- CADVaporizer, Anesthesia, Non-Heated
- CBKVentilator, Continuous, Facility Use
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain