Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005973280

FEI Number

3005973280

Entity Name

EMERALD INSTRUMENTS

City/State/Country

SIALKOT Punjab, PK

Establishment Address

FACTORY RORAS ROAD, P.O.BOX 766, SIALKOT Punjab --, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EMERALD INSTRUMENTS (Owner Number: 9045610)

Owner / Operator Contact Address

FACTORY RORAS ROAD,, P.O.BOX 766, SIALKOT, PUNJAB, PK-PB 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SCISSORS, EPISIOTOMY Forceps, ophthalmic CURETTE SCISSORS, OPHTHALMIC Retractor, ophthalmic ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY ELEVATOR, SURGICAL, DENTAL Dilator, lachrymal Syringe, cartridge INSTRUMENT, FILLING, PLASTIC, DENTAL SPECULUM, VAGINAL, METAL Specula, ophthalmic TWISTER, WIRE EXCAVATOR, DENTAL, OPERATIVE PLIER, ORTHODONTIC SCALER, PERIODONTIC Cannula, ophthalmic CURETTE, PERIODONTIC Knife, ophthalmic RETRACTOR HOLDER, NEEDLE, GASTROENTEROLOGIC DRIVER, SURGICAL, PIN FORCEPS, GENERAL & PLASTIC SURGERY BURNISHER, OPERATIVE INSTRUMENTS, DENTAL HAND FORCEPS, TOOTH EXTRACTOR, SURGICAL RASP FORCEPS HANDLE, SCALPEL FORCEPS, ARTICULATION PAPER PROBE, PERIODONTIC SCISSORS, MEDICAL, DISPOSABLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDK	Scissors, Episiotomy	Obstetrics/Gynecology	Class 1	884.4520	2018-04-16
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-08-07
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2018-07-26
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-08-16
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-08-07
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-12-03
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2017-06-21
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2006-08-07
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2023-04-05
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2023-04-05
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2007-12-07
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-08-07
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2013-09-06
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2023-04-05
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2007-12-03
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2007-12-07
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-08-16
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2019-04-05
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-08-16
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-10-13
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2007-12-03
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2018-07-26
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-04-25
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2019-08-08
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2007-12-07
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2007-12-07
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2018-07-26
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-09-06
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-09-06
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2019-04-05
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2019-04-05
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2001-04-17

Official Correspondent

No official correspondent registered.

US Agent Details

Johann Scanlan Business: Sontec Instruments Email: jscanlan@sontecinstruments.com Phone: (303) 7909411

Related Public Records

Same Entity

EMERALD INSTRUMENTS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
8040263	GLORIOUS MERCANTILE CORP. (PVT) LTD.	SIALKOT Punjab, PK
3010699884	ALFRAMED	Sialkot Punjab, PK
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
1646747	WEXLER SURGICAL, INC.	HOUSTON, TX, US
5906	SCHOBELL INDUSTRIAL LTDA	Rio Claro Sao Paulo, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005973280. Last updated year: 2026. Please use registration number 3005973280 when referencing this establishment in official correspondence.