Hood Laboratories
Pembroke, MA, US
Hood Laboratories appears in FDA device records in Pembroke, MA. FDA records list 19 510(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
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Hood Laboratories between 1985 and 1993. The busiest year on record is 1989, with 4. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 4 |
| 1990 | 2 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K921452 | ACOUSTIC RHINOMETER | BXQ | Substantially Equivalent | |
| K920994 | HOOD NASAL SEPTAL BUTTON | LFB | Substantially Equivalent | |
| K905703 | KRUPIN EYE VALVE WITH DISK | KYF | Substantially Equivalent | |
| K904821 | ELIACHAR MODIFIED ESOPHAGEAL STENT | ESW | Substantially Equivalent | |
| K897049 | GIBSON ENDOLYMPHATIC SHUNT | ESZ | Substantially Equivalent | |
| K897059 | HOOD SPEAKING VALVE | JOH | Substantially Equivalent | |
| K893866 | HOOD PEDIATRIC TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | |
| K884810 | SILICONE LARYNGEAL STENT | FWN | Substantially Equivalent | |
| K890599 | HOOD NASAL SPLINT | EPP | Substantially Equivalent | |
| K885125 | KRUPIN EYE VALVE W/SCLERAL BUCKLE | KYF | Substantially Equivalent | |
| K882430 | HOOD TRACHEAL STOMA BUTTON | BTO | Substantially Equivalent | |
| K873742 | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES | NWA | Substantially Equivalent | |
| K871244 | HOOD ESOPHAGEAL PROSTHESIS | ESW | Substantially Equivalent | |
| K864533 | HOOD BIFURCATED T-TUBE | BTR | Substantially Equivalent | |
| K854112 | FLEXIBLE GRASPING FORCEPS | EWL | Substantially Equivalent | |
| K853726 | LARYNGEAL | FWN | Substantially Equivalent | |
| K853511 | THE HOOD LIFE SAVER | BTO | Substantially Equivalent | |
| K853940 | THE GRONINGEN VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K853419 | CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE | BTO | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LFBButton, Nasal Septal
- KYFImplant, Eye Valve
- ESWProsthesis, Esophageal
- EWLProsthesis, Laryngeal (Taub)
- FWNProsthesis, Larynx (Stents And Keels)
- NWAProsthesis, Tracheal, Preformed/Molded
- BXQRhinoanemometer (Measurement Of Nasal Decongestion)
- EPPSplint, Nasal
- JOHTube Tracheostomy And Tube Cuff
- ESZTube, Shunt, Endolymphatic
- BTRTube, Tracheal (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
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
