Medical Device Manufacturer · US , Walker , MI

Exmoor Plastics , Ltd.

43 submissions · 43 cleared · Since 1981
43
Total
43
Cleared
0
Denied

Exmoor Plastics , Ltd. — FDA 510(k) Submissions

Exmoor Plastics , Ltd. has submitted 43 FDA 510(k) premarket notifications since 1981, of which 43 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tube, Tympanostomy, Instrument, Ent Manual Surgical, Splint, Nasal, Replacement, Ossicular Prosthesis, Total, Prosthesis, Partial Ossicular Replacement . Use the specialty filter in the sidebar to narrow results.

43 devices
1–25 of 43
EPIDRUM
K093863 · FMF Syringe, Piston · General Hospital
May 2010 144d
EXMOOR SUCTION CLEARANCE KIT
K990366 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Mar 1999 28d
EXMOOR MYRINGOTOMY KIT
K980828 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Oct 1998 233d
DILKES LASER/SUCTION CANNULAE
K981143 · GEX Powered Laser Surgical... · General & Plastic Surgery
Sep 1998 168d
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
K972700 · KHJ Polymer, Ent... · Ear, Nose, Throat
Jul 1998 393d
MILLS COLUMELLA PROSTHESIS
K981088 · ETA Replacement, Ossicular... · Ear, Nose, Throat
Jun 1998 72d
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K981045 · ETB Prosthesis, Partial... · Ear, Nose, Throat
May 1998 61d
PFLEIDERER'S INTRATYMPANIC CATHETER
K974008 · ETD Tube, Tympanostomy · Ear, Nose, Throat
May 1998 208d
ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
K974224 · ESZ Tube, Shunt, Endolymphatic · Ear, Nose, Throat
Jan 1998 78d
EXMOOR TYMPANOCENTESIS KIT (TK/1)
K973587 · JZF Tube, Ear Suction · Ear, Nose, Throat
Jan 1998 123d
MILLS INCUS HA SLEEVE
K974365 · ETB Prosthesis, Partial... · Ear, Nose, Throat
Jan 1998 64d
SHAH PERMAVENT
K974007 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Dec 1997 52d
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
K963899 · ETA Replacement, Ossicular... · Ear, Nose, Throat
Aug 1997 329d
EXMOOR SINGLE USE MYRINGOTOMES
K942745 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Sep 1994 84d
SUCKER ENDS (ZOELLNER)
K942746 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Aug 1994 75d
BEL-AIR VENTILATION TUBE
K926462 · ETD Tube, Tympanostomy · Ear, Nose, Throat
May 1993 132d
TITANIUM VENTILATION TUBES
K921923 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Feb 1993 310d
DEANS DISPOSABLE T-TUBE INSERTER
K924901 · JYM Inserter, Myringotomy Tube · Ear, Nose, Throat
Jan 1993 141d
SINGH SPEECH SYSTEM (SERIES 'SSS')
K912486 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Sep 1992 458d
EXMOOR SILICONE RUBBER SHEET
K911503 · KHJ Polymer, Ent... · Ear, Nose, Throat
Nov 1991 230d
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
K911580 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Sep 1991 174d
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
K911613 · LCR Fluorescent Immunoassay,... · Toxicology
Jun 1991 86d
EXMOOR BITE BUFFER
K893006 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Mar 1990 315d
'EXMOOR' SINGLE USE SUCTION TUBE
K892504 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Jun 1989 72d
SUNDERLAND NASAL TUBE
K883668 · BTQ Airway, Nasopharyngeal · Anesthesiology
Nov 1988 87d
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