Medical Device Manufacturer · US , Toledo , OH

Bionix Development Corp.

12 submissions · 12 cleared · Since 1990
12
Total
12
Cleared
0
Denied

Bionix Development Corp. — FDA 510(k) Submissions

Bionix Development Corp. has submitted 12 FDA 510(k) premarket notifications since 1990, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Accelerator, Linear, Medical, Blanket, Neonatal Phototherapy, Clamp, Circumcision . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
TruGuard Custom Tongue and Jaw Positioner
K153270 · IYE Accelerator, Linear, Medical · Radiology
Mar 2016 117d
LITTLE ANGELS SWADDLING BLANKET
K123411 · PDH Blanket, Neonatal... · General Hospital
Mar 2013 122d
EMBRACE THERMOPLASTIC
K120335 · IYE Accelerator, Linear, Medical · Radiology
May 2012 90d
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500
K100691 · IYE Accelerator, Linear, Medical · Radiology
May 2010 62d
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060
K100264 · IYE Accelerator, Linear, Medical · Radiology
Apr 2010 71d
THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010
K050701 · IYE Accelerator, Linear, Medical · Radiology
Apr 2005 14d
PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM
K040773 · IYE Accelerator, Linear, Medical · Radiology
Apr 2004 14d
VERSABOARD, MODEL 7040
K030051 · IYE Accelerator, Linear, Medical · Radiology
Apr 2003 88d
3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER
K933613 · IYE Accelerator, Linear, Medical · Radiology
Oct 1993 80d
PITUITARY BOARD
K933614 · IYE Accelerator, Linear, Medical · Radiology
Oct 1993 80d
STANDARD BREAST BOARDS; DELUXE BREAST BOARD
K905007 · IYE Accelerator, Linear, Medical · Radiology
Feb 1991 98d
ONE/CIRC (CIRCUMCISION CLAMP)
K900370 · HFX Clamp, Circumcision · Obstetrics & Gynecology
Apr 1990 81d
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All12 Radiology 10 Obstetrics & Gynecology 1 General Hospital 1