Biomaterials.info

powered by FreeFind

US Food and Drug Administration (FDA) - Orthopedic Devices Registration
FDA Registered Orthopedic Devices - Updated May 2006

What Is Medical Device Listing?

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. 		FDA Devices
FDA Devices
FDA Devices
FDA Devices


First Page Previous Page Next Page Last Page
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   REPROCESSED SURGICAL BURR
Proprietary Device Name:   BURR, ORTHOPEDIC
Registered Establishment Name:  SURETEK MEDICAL.
Classification:   TAP, BONE
Generic Device Name:   REPROCESSED BONE TAP
Proprietary Device Name:   TAP, BONE
Registered Establishment Name:  SURETEK MEDICAL.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   REPROCESSED CARPAL TUNNEL BLADE
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  SURETEK MEDICAL.
Classification:   BIT, DRILL
Generic Device Name:   REPROCESSED SURGICAL DRILL BIT
Proprietary Device Name:   BIT, DRILL
Registered Establishment Name:  SURETEK MEDICAL.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   RING FIXATOR CLAMP, RING STABILIZER, TOOL
Proprietary Device Name:   CLAW MASTER, TENSION BOOSTER
Registered Establishment Name:  QUANTUM MEDICAL CONCEPTS, LLC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   FEMORAL STYLUS TRIATHLON ASSEMBLY
Proprietary Device Name:   FEMORAL STYLUS TRIATHLON INSTRUMENTS
Registered Establishment Name:  VIASYS HEALTHCARE-INTERMED PRECISION SUBSIDIARY.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   DURACON PRESSFIT STEM COCR,DURACON,TI DURACON REG FLUTED STEM
Proprietary Device Name:   DURACON PRESSFIT STEM COCR,DURACON,TI DURACON REG FLUTED STEM
Registered Establishment Name:  STERIPACK LTD.,.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   ICA FEM COMP
Proprietary Device Name:   ICA FEM COMP
Registered Establishment Name:  STERIPACK LTD.,.
Classification:   COMPONENT, CAST
Generic Device Name:   VARIOUS TYPES CAST COMPONENTS
Proprietary Device Name:   K-LITE, VET-LITE, VARAFORM
Registered Establishment Name:  JUST PACKAGING INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   TRACTION SPLINT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TOP-LINE (HK) COMPANY.
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   HEAD TRACTION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TOP-LINE (HK) COMPANY.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   NECK TRACTION FIXER
Proprietary Device Name:   NECKSOFT PRO-5, NECKSOFT PRO-7
Registered Establishment Name:  YCY PROSPERITY HOLDINGS LTD.
Classification:   BONE MILL
Generic Device Name:   BONE MILL
Proprietary Device Name:   CANNULATED SCREWS, INSTRUMENT
Registered Establishment Name:  TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD..
Classification:   BONE MILL
Generic Device Name:   BONE MILL
Proprietary Device Name:   CANNULATED SCREWS, INSTRUMENT
Registered Establishment Name:  CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  LOGO TECH INTERNATIONAL.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  LOGO TECH INTERNATIONAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  LOGO TECH INTERNATIONAL.
Classification:   CALIPER
Generic Device Name:   CLAIPER, CLINICAL USE
Proprietary Device Name:   CLAIPER
Registered Establishment Name:  LOGO TECH INTERNATIONAL.
Classification:   SPLINT, TRACTION
Generic Device Name:   TRACTION SPLINT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TRICARE MEDICAL CO., LTD..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   HEAD TRACTION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TRICARE MEDICAL CO., LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  QAE ENTERPRISES.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  QAE ENTERPRISES.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  QAE ENTERPRISES.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  QAE ENTERPRISES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  UKPAK INTERNATIONAL.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  UKPAK INTERNATIONAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  UKPAK INTERNATIONAL.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  UKPAK INTERNATIONAL.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  SURGEON SURGICAL (PVT) LTD.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  EUROMED INDUSTRIES.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  EUROMED INDUSTRIES.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  EUROMED INDUSTRIES.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  EUROMED INDUSTRIES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL
Proprietary Device Name:   MULTIPLE PRODUCT NAMES
Registered Establishment Name:  Y. Z CORPORATION.
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   MOTUS MOVEMENT MONITOR
Proprietary Device Name:   MOTUS MOVEMENT MONITOR
Registered Establishment Name:  MOTUS BIOENGINEERING INC..
Classification:   CERCLAGE, FIXATION
Generic Device Name:   STERNAL WIRE
Proprietary Device Name:   STERNA-BAND
Registered Establishment Name:  PENINSULA MEDICAL L.L.C..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DELTA SURGICAL INSTRUMENTS, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DELTA SURGICAL INSTRUMENTS, INC..
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DELTA SURGICAL INSTRUMENTS, INC..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS TYPES OF CAST REMOVAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DELTA SURGICAL INSTRUMENTS, INC..

First Page Previous Page Next Page Last Page




Last Modified: 29 April 2006
http://www.biomaterials.info
Sitemap
Link | Link | Link | Link | Link | Link | Link | Link