Medical Device Manufacturer · US , Orange City , IA

Medtec, Inc.

41 submissions · 41 cleared · Since 1993
41
Total
41
Cleared
0
Denied

Medtec, Inc. — FDA 510(k) Submissions

Medtec, Inc. has submitted 41 FDA 510(k) premarket notifications since 1993, of which 41 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Accelerator, Linear, Medical, Monitor, Patient Position, Light-beam, Block, Beam-shaping, Radiation Therapy, Shield, Eye, Radiological, Table, Radiographic, Stationary Top . Use the specialty filter in the sidebar to narrow results.

41 devices
1–25 of 41
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
K132908 · IYE Accelerator, Linear, Medical · Radiology
Mar 2014 168d
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
K111340 · LNH System, Nuclear Magnetic... · Radiology
Jun 2011 47d
MRI PATIENT POSITIONING DEVICES
K093738 · LNH System, Nuclear Magnetic... · Radiology
May 2010 161d
CARBON FIBER BREAST BOARD
K974703 · IYE Accelerator, Linear, Medical · Radiology
Mar 1998 84d
MATRIX MT-MX3
K974700 · IYE Accelerator, Linear, Medical · Radiology
Mar 1998 78d
CARBON FIBER CONFORMAL COUCH TOP
K973842 · IXQ Table, Radiographic,... · Radiology
Dec 1997 58d
INTRA-ORAL THERMOPLASTIC SHIELD
K962622 · KPY Shield, Protective,... · Radiology
Oct 1996 88d
GREEN TEC-2100
K955236 · IWE Monitor, Patient... · Radiology
May 1996 192d
ACRYSTEEL BLOCKING TRAY
K954705 · IYE Accelerator, Linear, Medical · Radiology
Jan 1996 85d
THERMOPLASTIC SHIELD
K954456 · KPY Shield, Protective,... · Radiology
Dec 1995 87d
MED-TEC HAND GRIP
K954225 · IXQ Table, Radiographic,... · Radiology
Nov 1995 64d
MEDTEC AUTOBLOT 2000
K951753 · JQW Station, Pipetting And... · Microbiology
Oct 1995 183d
PAINTED WEDGE & ROD BREAST BOARD
K952729 · IYE Accelerator, Linear, Medical · Radiology
Sep 1995 92d
TEC-2110 GREEN LASER MODEL MT-HNG
K950293 · IWE Monitor, Patient... · Radiology
Aug 1995 205d
MED-TEC REDISET
K952189 · IYE Accelerator, Linear, Medical · Radiology
Aug 1995 92d
MED-TEC TRAY ADAPTER
K950075 · IYE Accelerator, Linear, Medical · Radiology
Jul 1995 185d
MED-TEC TESTICULAR SEPARATOR
K951679 · IYE Accelerator, Linear, Medical · Radiology
Jul 1995 92d
MED-TEC RADIO THERAPY TREATMENT CHAIR
K951947 · IYE Accelerator, Linear, Medical · Radiology
Jul 1995 77d
MED-TEC REDI-FOAM
K951808 · IYE Accelerator, Linear, Medical · Radiology
Jul 1995 78d
MED-TEC KNEE CRUTCH
K951717 · IYE Accelerator, Linear, Medical · Radiology
Jun 1995 76d
COATED TUNGSTEN EYESHIELD
K945515 · IWS Shield, Eye, Radiological · Radiology
Jun 1995 222d
HIP FIXATION SYSTEM
K950866 · IYE Accelerator, Linear, Medical · Radiology
May 1995 92d
MED-TEC STRING RETICLE TRAY
K951601 · IWE Monitor, Patient... · Radiology
May 1995 34d
CARBON FIBER COUCH INSERT
K950068 · KXJ Table, Radiologic · Radiology
Apr 1995 87d
TUNGSTEN EYESHIELD
K943011 · IWS Shield, Eye, Radiological · Radiology
Dec 1994 182d
Filters