General & Plastic Surgery › Diagnostic

Which Manufacturers in China Work in This Section?

14 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Jiangsu, Zhejiang and Guangdong, and 3 other provinces. 2 of them are contract manufacturers. Chinese manufacturers are registered for 6 of 10 device types here.

None of those device types needs a premarket submission before sale in the United States. The FDA has recorded 5 recalls across the section’s product codes; the root causes it names most often are Process control (2), Software design (1) and Device Design (1).

Which Device Types Are Made in China?

The device types with the most Chinese manufacturers are Speculum, Ent (9), Specula Accessories (3), Speculum, Illuminated (3), Speculum, Non-Illuminated (3) and Holder, Ear Speculum (2). All 6 device types in this section with a Chinese manufacturer, most manufacturers first:

Speculum, Ent 9 manufacturers
Specula Accessories 3 manufacturers
Speculum, Illuminated 3 manufacturers
Speculum, Non-Illuminated 3 manufacturers
Holder, Ear Speculum 2 manufacturers
Holder, Speculum, Ent 1 manufacturer

Bear

Bruenings Set, Complete w Head, Bulb, 4 Specula and Case

MicroFrance®

MicroFrance® Rouvier self retaining speculum, serrated blades, working length 75 mm

Symmetry Cottle

Symmetry® Speculum, Cottle Nasal, Narrow Tapered, 75 mm Blades, Self-Retaining, 5 1/2 in, 139 mm

Boss Instruments

Replacement Ebonized set screw for items 93-1760 through 1766

Fentex

Nasal Speculum by Beckmann 15 cm, blade length 22 mm, Size 1 ***Minimum Order Qty. 5 pcs. ***

Symmetry Gruber

Symmetry® Speculum, Gruber, Chrome Plated, Oval, 6.0 mm x 7.2 mm, 42.0 mm

Surgipros

Specula Ear 5.5X6.5mm, Oval, Oblique, Ebony

Speculum, Non-Illuminated

MSI Precision Specialty Instruments

Hinkle-James Rectal Speculum, Tapered From 16mm To 51mm (5/8" To 2"), Overall Length 4-3/8" (111mm)

BR Surgical, LLC

GRUBER Ear Specula, oval, light, short pattern, child & infant size, 3x4mm, 33.5mm height

Aesculap

Gruber Speculum Oval END SZ3 3.2X4.7MM 36MM

Millennium

Farrior Speculum, Size 6 Oval, Oblique, Outer Diameter 11.5mm x 10.5mm, OL 42mm(1 5/8")

Killian Septum Speculum

with fibre light carrier 40 mm, 14 cm

Mytamed

Gruber Ear Specula, XL, Oval, 42mm, 7.0 x 8.2mm

Pilling

Forbes Esophageal Speculum Adult

Evonos GMBH & Co. Kg

EAR Surgery Speculum Round 3.0MM Beveled

MSI Precision Specialty Instruments

Cottle Nasal Speculum, Extra-Long 90mm Blades, Tapered From 8mm To 10mm Wide, Set Screw, Working Length 3-1/2" (90mm), Overall Length 5 1/8" (130mm)

RZ Medizintechnik GmbH

Killian-Cottle Nasal Speculum 55mm, slightly tapered blades, 140mm 5 1/2", screw joint, w/ locking screw

Holder, Ear Speculum

MicroFrance®

MicroFrance® Darrouzet flexible tension arm

V. Mueller

V. Mueller MERZ-VIENNA NASAL SPECULUM MEDIUM, BLADE 25 X 6.3MM LIGHT, WITH DELICATE SPRING OVERALL LENGTH 5-3/8 inches 13.6CM

Sinus Speculum for Adults

right blade 65 mm

HNM Medical

Cottle Nasal Speculum, 5 1/2", 90MM Blade, Self Retaining, Narrow Tapered

Gen2

Vienna Nasal Speculum, #2, 30MM Blades, Overall 5.3'' (134MM)

Symmetry Tebbets

Symmetry® Speculum, Tebbetts Style, 1 3/4 in (45 mm) Thin Blades, 6 in

Gimmi

Cottle Nasal Specula Extra Thin Blades, 50 MM Length 145 MM

Rosen Round Ear Specula 3mm

2 catalogue numbers from ESP0203, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Medicon

Killian nasal speculum 15cm lf serr 35mm rt 55mm w conn

Sklar®

Wire Spec Temp APP Nasal SD 2 Inches

Novo Surgical

zenith cottle septum speculum, self-retaining, side adjusting set-screw, narrow tapered blades, 5-1/2" (14.0 cm), blade length: 35.0 mm

Integra®

Integra® Farrior Speculum, 1-3/4", Oval Oblique Ends, 10.0mm x 12.0mm, 1-3/4", Size 6

Speculum

EAR, Zoellner, NO. 5, Oval, Black, 9.5 X 10.5 MM

Specula Accessories

Ambler Surgical

Shea ear speculum holder, 11 3/4''

Pack of 10 Pcs. Reusable Ear Specula Ø 4 Mm,

Catalogue number 10800-534, listed by Rudolf Riester Gmbh, Germany, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Integra® Miltex®

Integra® Miltex® Gruber Ear Specula Set of 4, Short Oval, with Case, Includes:(REF #'s 19-14, 19-16, 19-18, & 19-20)

Symmetry Farrior

Symmetry® Speculum, Farrior Ear, Ebonized, Oval Oblique, #5, 9.0 mm x 10.5 mm Outside Diameter

Integra® Jarit®

Integra® Jarit® Gruber Ear Specula Set of 4, Short Oval, without Case, (REF #'s X2025, X2027, X2029, X2031)

Marina Medical

Marina Specula Adapter to fit Marina Light Cord

Pack of 1000 Pcs. Disposable Ear Specula Ø 2,5 Mm,

Catalogue number 10774-531, listed by Rudolf Riester Gmbh, Germany, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Jedmed

Speculum EAR Hartmann Oval Ebony Size 1

Ear Specula – 3mm Non-Sterile

2 catalogue numbers from NZ3233-100, listed by Adept Medical Ltd, New Zealand, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Geiz

Vienna Nasal Specula, No.2, Medium *** Geiz Line ***

Ambler Surgical

Farrior ear speculum, oval, oblique ends, set of 11 includes sizes #1 - #11 (86-210, 86-211, 86-212, 86-213, 86-214, 86-215, 86-216, 86-217, 86-218, 86-219, and 86-220), black ceramic finish

Inka

COTTLE black Septum Speculum sz:2 (50mm) thin blades with set-screw 14.5cm

Holder, Ear Speculum

Bear

Universal Speculum Holder, Mount

Hartmann-Halle Nasal Speculum

3 catalogue numbers from 20-110-02, listed by Spiggle & Theis Medizintechnik Gmbh, Germany, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Gyrus Acmi

EAR Speculum Adult, 5 MM Disposable

Surtex

Cottle Nasal Speculum Extra Thin Profile Fig. 3 - With Screw Fixation 13.5 cm - 5 1/4" Blade Length 75 mm Stainless Steel

Bausch + Lomb

Spec FAR Orig MDL Oval Oblq #4

Hayden Medical

Killian Nasal Speculum 5" (13cm), with set screw, 2" (5cm) long blades, FIBER-OPTIC with universal connector

Instrapac

Instrapac Thudicum Nasal Specula Size 6 X 40

EOS

EOS Brand Disposable Otoscope III (Lock) - 4.0MM Smaller (Heine)

Symmetry Killian

Symmetry® Speculum, Nasal Killian Lateral Set Screw, 75 mm Long Blade, Right Blade

Symmetry Toynbee

Symmetry® Speculum, Toynbee, Round, Chrome-Plated, 6.0 mm End, 35.0 mm

Speculum, Ent

Cottle Nasal Speculum; 5-1/2"(14CM), W/ F/O, 45MM Blades, Delicate

Ear Specula – 6mm Non-Sterile

2 catalogue numbers from NZ3230-100, listed by Adept Medical Ltd, New Zealand, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Novo Surgical Inc.

cottle septum speculum, self-retaining, side adjusting set-screw, narrow tapered blades, 5 1/2" (14.0 cm), blade length: 75.0 mm

Ear Specula, Autoclavable, for Beta 200

and mini 3000, black, set of 4 sizes 1 set

Hartmann Ear Speculum

for post treatment, size 2 OD 10.0 mm, ID 9.0 mm, satin finished

Killian Septum SPECULA-3″ Blad

Catalogue number 10-7157, listed by W.H. Holden, Inc., under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Speculum, Non-Illuminated

Ambler Surgical

Barr self-retaining anal retractor, 8'', 2 3/4'' deep x 7/8'' wide blades, ring handle with ratchet catch

Stille Retractors

NASAL SPECULUM COTTLE STILLE 55 mm with set screw 14 cm 5.5 in

Avalign

Boucheron Speculum Set Round, Small Set of Four OL 33mm(1 1/4")

Holder, Ear Speculum

Medicon

universal holder f Ø 2.7-10mm

VorOtek Speculums

VorOtek Speculums - Medium. Pack of 50 Medium Speculums. Autoclavable plastic

Farrior Ear Speculum

size 9, 35°, oval, black ID 7.5x8.5 mm, OD 8.5x9.5 mm

Tumarkin Ear Specula Size 0 (3.5mm)

2 catalogue numbers from TSP05000, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Speculum, Non-Illuminated

Princeton

Speculum Hill-Ferguson Rectal 2.2 X 6.4CM Blade 8" Black Coated

Killian Septum Speculum

Killian Septum Speculum With Fiber Optic Light 3 Inch Thin Low Profile Blades

Holder, Ear Speculum

Intrace USA

Hartmann Ear Speculum, Adult Size, 3 mm Diameter (Tip), 33–35 mm Length, Stainless Steel (or Chrome Plated), Reusable.

Toynbee Ear Specula

size 2 4.0 mm

Bear

Gruber Ear Specula, XL, Oval, 42mm, 7.0 x 8.2mm

Van Sickle

Cottle Septum Speculum 5-1/2" (140 mm) 50mm thin modified blades

Ambler Value Line

Cottle septum speculum, 5 1/2'', narrow, 90.0mm long, tapered 10mm to 8mm wide blades, with set screw

Reusable Ear Specula Ø 2 Mm,

Catalogue number 10460, listed by Rudolf Riester Gmbh, Germany, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Speculum, Illuminated

EZY Dose Kids

Mediscope KIT 2/24

Thudichum Nasal Specula Sizes 1, 2 & 3

Catalogue number TNS2003, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Holder, Speculum, Ent

Lazic

Nasal Specula Cottle 90 X 10-8 MM FOR 70.589.01 - 70.589.03 Total Length 140 MM / 5 1/2"

Medetz Surgical Instruments

Gruber Speculum, Round, Heavy, Long #1, Outer Diameter 5.5mm

Pack of 10 Pcs. Reusable Ear Specula Ø 3.0 Mm,

Catalogue number 10834, listed by Rudolf Riester Gmbh, Germany, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

WiscMed

A single use, plastic, rigid, cone shaped, speculum designed specifically for use with the WiscMed Wispr digital otoscope. This item number consists of a quantity of 300 specula, packaged…

Tumarkin Ear Specula Size 1 (5.5mm)

2 catalogue numbers from TSP02010, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Carnegie Surgical LLC

FARRIOR (RICHARDSON) ear speculum oval IØ6.5x7.5mm OØ7.3x8.3mm, stainless steel, black ebony finish

Adler Instrument Company

Halle nasal Speculum Size2, Medium BL 32mm, OL160mm (6-1/4")

Holder, Ear Speculum

Tumarkin Ear Specula Size 0.5 (4.5mm)

Catalogue number TSP02005, listed by DTR Medical Ltd, United Kingdom, under Holder, Ear Speculum. 2 manufacturers in China are registered for this product code.

Cottle Speculum

Cottle Speculum Extra Delicate Blades Black Ebony Coated

Kmedic

Gruber EAR Speculum Adult # 2 Chrome

Ear Specula – 10mm Non-Sterile

2 catalogue numbers from NZ3235-5, listed by Adept Medical Ltd, New Zealand, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Trapezoidal Speculum, 70x13mm Jaw, Up

Catalogue number 07-927-06MA, listed by Mizuho America, Inc., United States, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Symmetry Vienna

Symmetry® Speculum, Vienna Nasal, 32 mm Blades, #3, 5 1/4 in, 133 mm

Rosen Round Ear Specula 7mm

2 catalogue numbers from ESP0207, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Symmetry Hartmann

Symmetry® Speculum, Hartmann, Oval, #4, 7.0 mm x 8.0 mm

Papavero Speculum, 90x13mm Jaw

Catalogue number 07-907-07, listed by Mizuho America, Inc., United States, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Aztec

Hartman Ear Speculum, Infant, round

Papavero Speculum, Titanium, 80x13mm Jaw

Catalogue number 07-917-06MA, listed by Mizuho America, Inc., United States, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Symmetry Surgical®

Symmetry® Speculum, Septum, Very Narrow Blade, 50 mm Blades, Ebony Finish, 5 1/2 in, 139 mm

NAR

SPECULA, SMALL DISPOSABLE - PKG/50 2.5 mm

Single-Use Rosen Round Ear Specula 3mm, Non Sterile

Catalogue number ESP1003, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Nasal Speculum

Nasal Speculum Infant

Cottle Septum Speculum

extra thin blades, black, with screw 75 mm, 13 cm

Centurion

Sterile Round EAR Speculum SET (3, 4, 5)

Oval Ear Specula Size 4 (6.0mm)

2 catalogue numbers from OSP0204, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Surjex

Killian Nasal Speculum 6" 50mm Blade With Set Screw Killian Nasal Specula 5" 75mm---3"Blade With Set Screw Killian Nasal Spectula 5" 90mm Blade With Set Screw Killian Nasal Specula 5" 35mm…

V. Mueller

Bruening Speculum Medium Round TIP 5MM I.D.

Symmetry Boucheron

Symmetry® Speculum, Boucheron, Chrome Plated, Round, Large, 5.5 mm To 9.0 mm, (4/st)

Hartmann Halle Nasal Speculum

Hartmann Halle Nasal Speculum Medium Size Quantum

Rosen Round Ear Specula 5mm

2 catalogue numbers from ESP0505, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Symmetry Halle

Symmetry® Speculum, Halle Nasal, 32 mm Blades, 6 1/4 in, 158 mm

Zöllner Ear Speculum

size 4, light metal, black ID 7.5x8.5 mm, OD 8.5x9.5mm, length 38mm

Manus Medical, LLC

Sterile Vienna Speculum

Vienna Nasal Speculum

Vienna Nasal Speculum #1 Small Size 24 Millimeters Blades Quantum

Bionix Development Corporation

Disposable Speculum-48 count

Tieck-Halle Infant Nasal Speculum

Tieck-Halle Infant Nasal Speculum Stainless Steel Quantum

Specula Accessories

Ocular Exam Depressor

Disposable Depressor

Modified Cottle Nasal Speculum

Modified Cottle Nasal Speculum 38 Millimeters Thin Wide Blades Quantum

Tieck-Halle Nasal Speculum for Children

for children, dismountable 21 mm, 13 cm

Transsphenoidal Pituitary Speculum

Transsphenoidal Pituitary Speculum Sand Blasted Surface

Gruber Ear Specula

size 2, oval Ø 5.0x6.2 mm

Single-Use Shea Ear Specula Size 1 (3.5mm X 4.1mm) Non Sterile

Catalogue number SSP1001, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

Oval Ear Specula Size 3 (4.0mm)

2 catalogue numbers from OSP0503, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

ADC

Reusable Specula-5210/11/15/20,Size 2.5mm, 3.5mm, 4.5mm

Oval Ear Specula Size 2 (3.5mm)

2 catalogue numbers from OSP0502, listed by DTR Medical Ltd, United Kingdom, under Speculum, Ent. 9 manufacturers in China are registered for this product code.

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