Probe

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shanghai and Shandong, and 1 other province: 12 hold an FDA registration. 3 are contract manufacturers.

Changzhou Xietong Industries Co., Ltd. Jiangsu
Hangzhou Haizhu MIM Products Co., Ltd. Zhejiang
Hangzhou Ruihao Medical Technology Ltd Zhejiang, contract manufacturer
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer
Shanghai KiNETIC Medical Co Ltd Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Shanghai Reach Medical Instrument Co., Ltd. Shanghai
Suzhou Endophix Co., Ltd. Jiangsu
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer

What Is FDA Product Code HXB?

Probe is FDA product code HXB, Class 1, 21 CFR 888.4540.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Process change control (1) and Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Probe

Probe With 1.8MM Cannula FOR 5.0MM & 6.0MM & 7.0MM Screws

Symmetry Craig

Symmetry® Wrench, Craig Vertebral Body Biopsy, Socket

Probe

MODIFIED INSTRUMENT LONG DUAL END FEELER PROBE, 2.0mm

Sklar®

Moynihan Gall Stone Probes 13 Inches

Tecomet

Bone Probe, Straight Palm Impactor .125W, Small Taper 9.53", Orange

Tosca

35 catalogue numbers from Trial, 1-level, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

Tetris ST

65 catalogue numbers from Trial, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

RZ Medizintechnik GmbH

Jako-Type Laryngeal Probe 90° angled, 295mm, 11 3/4'', w-l 220mm, 8 1/2''

Medtronic Reusable Instruments

Probe EX0218015 Ball Handle Thorcic Shrt

General Instrument

Thinner Invictus OCT Straight Gearshift Probe, Round Handle

Solanas

Thoracic Ball TIP Probe

Reform Pedicle Screw System

Duckbill Pedicle Probe

General Instruments

StraightIliac Probe, Long, Ball Handle, Depth Marking

Operace

Sterile singel-use trials. Identify the size of the sterile screwdriver insert

Life Instruments

Custom 10.5" Flexible Ball Probe Str w/1mm Ball

TSI

Bayoneted Long Ball Probe, 11 MM, Black

Invictus

Inner Wire Assembly, Cannulated Iliac Probe, Ball Handle

Probe

154 catalogue numbers from 00-4216-001-10, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Probe. 12 manufacturers in China are registered for this product code.

Mariner

Bone Probe - Lenke Straight, Silicon

Subtalar MBA Implant System

Catalogue number 051002, listed by Smith & Nephew, Inc., United States, under Probe. 12 manufacturers in China are registered for this product code.

SeaSpine Spacer System – Hollywood

Concave Pusher, Short

Millennium

Bunnell Tendon Passer and Forwarding Probe, straight, 9"

Expedium

EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE, STRAIGHT, SMALL 10-40mm Plus or Minus 2.50 Percent

Aesculap

JACOBSON Probe Ball Pointed, straight, 7 1/4", (185 mm), 2 ball points, non-sterile, reusable

Probe

Probe EX0819016 Long Sounding/Feeler 1MM

Mobis

32 catalogue numbers from Trial, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

General Instrument

Thoracic Lenke Probe, Curved, 255mm Length

Inertia® Pedicle Screw and Deformity Correxxion® System

Probe, Lenke Straight, Iliac, Gear

Medtronic Resuable Instruments

Probe EX1016034 BLL Hndl Thorcic Stright

Innomed, Inc.

Standard Short Light Wand Only (.187 x 3)

Anax 5.5 Spinal System

36 catalogue numbers from SFDS1003, listed by CG MedTech Co., Ltd., South Korea, under Probe. 12 manufacturers in China are registered for this product code.

Boss Instruments

Kistner Probe & Dissector 212mm, 8 1/4"

Golden Isles Pedicle Screw System

Duckbill Pedicle Probe, Straight

SFS

Bone Probe Straight 4.5MM SFS Hook System

Gsource

Hook Probe 9", 2.5mm blunt, 5mm grad lines, shaft only for detach handle gS 30.2400

Malibu

Thoracic Probe, Curved, Square TIP, LG Handle

Probe

Latarjet EXPERIENCE, Latarjet, Small Probe

Specials

Bone Probe - Lenke Straight, Palm Style Handle, Thick Tip

Ennovate

Ennovate Thoracic Pedicle Probe STR LRG.

Athlet

29 catalogue numbers from Trial, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

Futura

Probe Instrument Assembly

Hermann Medizintechnik GmbH

SIMS uterine sound, graduated,malleable, length 32cm

Orthros

Thoracic Pedicle Probe, Duckbill, Straight, Ball Handle

Curved Thoracic Probe W/ Lenke

Catalogue number LV00518, listed by Highridge Medical, LLC, United States, under Probe. 12 manufacturers in China are registered for this product code.

Response Spine System

Hourglass Feeler Probe, Double Flex

CosmoLock Pedicle Screw System

Probe, 1.5 inch Ball, Lenke, Thoracic, Straight, Black

Polaris 5.5 Spinal Fixation System

Straight Lumbar Pedicle Probe

Symmetry Surgical

Symmetry® Director, Grooved w/Tongue Tie, Probe End, Stainless Steel, 5 1/8 in, 130 mm

Tasmin R

47 catalogue numbers from Trial, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

Probe

Nerve Root Retractor Edgefold Right WL 115mm, width 8mm

Acura Stabilization System – Straight Lenke Probe

Straight Lenke Probe

Semial

22 catalogue numbers from Trial, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

Mergence™-S

17 catalogue numbers from 96-101-03071, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Probe. 12 manufacturers in China are registered for this product code.

Probe

Nerve Probe, L-Shape, Shaft OD: 4.0mm, Tip OD: 1.5mm, WL: 152.0mm

Anax™ OCT Spinal System

8 catalogue numbers from OSS0500, listed by CG MedTech Co., Ltd., South Korea, under Probe. 12 manufacturers in China are registered for this product code.

General Instrument

7.5mm Lenke Probe

Gauthier Biomedical

Probe, Thoracic Straight

Vulcan™ Spinal System

Straight Thoracic Probe, Grooved

Excella®

Pedicle Marker, Cylinder, Excella-P, SST

Mobis II

20 catalogue numbers from Trial, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

Spinal System

Catalogue number 140M1200, listed by Biomet Spine, United States, under Probe. 12 manufacturers in China are registered for this product code.

Custom

Left AND Right Pedicle Markers Left & Right

S4 Cervical

S4C Pedicle Probe W/Button STR

Assi

Tenolysis Double Ended Pulley Dilator 3-5mm and 4-6mm

Ascent

Bone Probe, Ascent LE/Ascent Poct

Easyspine

Catalogue number ES9017R, listed by Ldr Spine USA, United States, under Probe. 12 manufacturers in China are registered for this product code.

Firebird Sfs,special Products

Straight Bone Probe, Large

Vital Spinal Fixation System

Probe, Thoracic, Small Straight

The Tether Vertebral Body Tethering System

Right Angle Sounder

HPS Pedicle Probe

2 catalogue numbers from HAT50300, listed by Paradigm Spine GmbH, Germany, under Probe. 12 manufacturers in China are registered for this product code.

Perla ® TL

Pelvic Probe Square - Curved

ACE

Probe Implant PCPNT11.5B Titanium 6" 15CM Markings 8-10-13-15-18MM

Firebird NXG

Straight Duckbill Probe

Hayden Medical

Tendon Passer Pointed Tip 6" (15cm), 8mm pointed tip, straight

BR Surgical, LLC

COHEN intra-uterine probe, complete w/ small & big portioadaptor

Stryker

Ball Probe, Straight Bayonet, 2MM, 7 MM Offset

Bencox DA Instruments Hip System

Blunt Curved Canal Finder

BMT Medizintechnik GmbH

Tatum Spreader #1, Markings 13-16-19MM W

Mariner Deformity

Iliac Probe, Straight, Sharp, Cannulated

Arsenal

4.0mm Straight Trocar Tip Probe, Ball Handle

Polaris 5.5 Spinal System

Curved Thoracic Probe, Large

Medicon

Ralk (Virtus) splinter fcps str 14cm

Sklar Instruments

Econo Sterile Probe W/EYE Tray CS/50

Wombat

7 catalogue numbers from Trial, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

Medfix

Medfix® Karlin Style Lumbar Microdiscectomy Penfield #1, 9 1/2" (240mm)

Virage OCT Spinal Fixation System

Sounding Probe

Princeton

Lachrymal Probe Bowman Stainless STEEL.6/.7MMØ FIG. 0000/000

Arthrex®

Ball Tip Probe, Shaft, Flexible, 330mm

Pass LP 2.0

Feeler A02310000 Pedicle Feeler Stiff

Vilex EPF/Mend Endoscopy Systems

Probe, EPF/MEND

Cosmolock

Probe, 1.75" Egg, Steffee, Long, Straight, Impact

Rabea

12 catalogue numbers from Trial, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

4mm Probe 90°

4mm Probe 90°: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Probe. 12 manufacturers in China are registered for this product code.

Impact Initial

2 catalogue numbers from 31-112102, listed by Biomet Orthopedics, United States, under Probe. 12 manufacturers in China are registered for this product code.

Moss

MOSS MIAMI MAGNUM SPINE SYSTEM PEDICLE PROBE, STEFFEE CURVED 6.35 30-60mm Plus or Minus 1.33 Percent

Introducer Probe – Stepped Collar

Catalogue number TET-INS-004, listed by Tetrous, Inc., United States, under Probe. 12 manufacturers in China are registered for this product code.

Probe

Symmetric Balancing Shim 2MM

LineSider

Gear Shift Duck Bill Straight

Novo Surgical

bayonet ball probe, 9.0 mm, angled right, 6" working length

SpineTune TL

3 catalogue numbers from ST9008R, listed by Ldr Spine USA, United States, under Probe. 12 manufacturers in China are registered for this product code.

Omnia Medical Instruments

big handled lenke probe

MSI Precision Specialty Instruments

MIS Woodson Probe, Bayonet, Black Coated, 6mm Width, Working Length 6" (150mm), Overall Length 10-3/4" (270mm)

Horizon Subtalar Gen 2 Sizing Probe 12mm

Catalogue number 22661, listed by Biopro, Inc., United States, under Probe. 12 manufacturers in China are registered for this product code.

Ambler Surgical

Chondro micro fracture pick, 25° angled tip, ergonomic carbon fiber handle

HNM Medical

Meniscus Hook Probe Instruments, Graduated Marks, 5MM Size

Nexgen®

17 catalogue numbers from 00-5879-065-29, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Probe. 12 manufacturers in China are registered for this product code.

Mega Plus Spine System

Straight Probe(Lenke)

CorticaLINK

Curved Pedicle Probe

Probe

Lenke Pedicle Probe w/ Sightline Groove

Starfire™ Pedicle Screw System

UNIV,PROBE,BALL-TIP,DUAL,90DEG

Monarch

MONARCH SPINE SYSTEM SEMI-CURVED PEDICLE PROBE 10-50mm Plus or Minus 1.50 Percent

NewPort

Extended Cannulated Straight Thoracic Probe

Sierra

Cervical Sounder

MEGA5.5 Spine System

Straight Probe

Polaris 4.75 Deformity System

4.75 TI Pedicle Sound, Medium

Probe

Double Ended, Button, 1.5 MM Tips

Noval

12 catalogue numbers from Trial, listed by Signus Medizintechnik Gmbh, Germany, under Probe. 12 manufacturers in China are registered for this product code.

Romeo 2 Instrumentation

Pedicle Probe Small

Sterile Spine Pedicle Screw System

Probe, Palm, Duckbill, Lumbar, Straight

Firebird SFS

Straight Bone Probe, Small

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer