Medical Device Manufacturer · US , Pembroke , MA

Hood Laboratories

19 submissions · 18 cleared · Since 1985
19
Total
18
Cleared
0
Denied

Hood Laboratories — FDA 510(k) Submissions

Hood Laboratories has submitted 19 FDA 510(k) premarket notifications since 1985, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tube, Tracheostomy (w/wo Connector), Prosthesis, Larynx (stents And Keels), Prosthesis, Laryngeal (taub), Prosthesis, Esophageal, Implant, Eye Valve . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
ACOUSTIC RHINOMETER
K921452 · BXQ Rhinoanemometer... · Anesthesiology
Jul 1993 469d
HOOD NASAL SEPTAL BUTTON
K920994 · LFB Button, Nasal Septal · Ear, Nose, Throat
May 1992 74d
KRUPIN EYE VALVE WITH DISK
K905703 · KYF Implant, Eye Valve · Ophthalmic
Mar 1991 85d
ELIACHAR MODIFIED ESOPHAGEAL STENT
K904821 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
Jan 1991 82d
GIBSON ENDOLYMPHATIC SHUNT
K897049 · ESZ Tube, Shunt, Endolymphatic · Ear, Nose, Throat
Mar 1990 88d
HOOD SPEAKING VALVE
K897059 · JOH Tube Tracheostomy And... · Anesthesiology
Mar 1990 84d
HOOD PEDIATRIC TRACHEOSTOMY TUBE
K893866 · BTO Tube, Tracheostomy (w/wo... · Anesthesiology
Aug 1989 73d
SILICONE LARYNGEAL STENT
K884810 · FWN Prosthesis, Larynx... · Ear, Nose, Throat
May 1989 174d
HOOD NASAL SPLINT
K890599 · EPP Splint, Nasal · Ear, Nose, Throat
Mar 1989 39d
KRUPIN EYE VALVE W/SCLERAL BUCKLE
K885125 · KYF Implant, Eye Valve · Ophthalmic
Jan 1989 43d
HOOD TRACHEAL STOMA BUTTON
K882430 · BTO Tube, Tracheostomy (w/wo... · Anesthesiology
Jun 1988 14d
HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES
K873742 · NWA Prosthesis, Tracheal,... · General & Plastic Surgery
Oct 1987 15d
HOOD ESOPHAGEAL PROSTHESIS
K871244 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
Apr 1987 17d
HOOD BIFURCATED T-TUBE
K864533 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Mar 1987 111d
LARYNGEAL
K853726 · FWN Prosthesis, Larynx... · Ear, Nose, Throat
Mar 1986 187d
FLEXIBLE GRASPING FORCEPS
K854112 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Mar 1986 155d
THE HOOD LIFE SAVER
K853511 · BTO Tube, Tracheostomy (w/wo... · Anesthesiology
Dec 1985 120d
THE GRONINGEN VOICE PROSTHESIS
K853940 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Dec 1985 80d
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
K853419 · BTO Tube, Tracheostomy (w/wo... · Anesthesiology
Dec 1985 114d
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