Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003407244

FEI Number

3003407244

Entity Name

T.A. WALTHEM & COMPANY

City/State/Country

SIALKOT PUNJAB, PK

Establishment Address

SUBLIME CHOWK, WAZIRABAD RD., SIALKOT PUNJAB PB 51310, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

T.A. WALTHEM & COMPANY (Owner Number: 9073915)

Owner / Operator Contact Address

SUBLIME CHOWK, WAZIRABAD RD., --, SIALKOT PUNAJB, PK-NOTA PB 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Specula, ophthalmic MALLET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT RASP, SURGICAL, GENERAL & PLASTIC SURGERY TROCAR, LARYNGEAL HANDLE, INSTRUMENT, DENTAL OSTEOTOME, MANUAL RASP, NASAL KNIFE, ORTHOPEDIC CLAMP, RUBBER DAM EXPLORER, OPERATIVE HAMMER, SURGICAL SCISSORS, ORTHOPEDIC, SURGICAL CLAMP PROBE CATHETER AND TIP, SUCTION Forceps, ophthalmic SCALER, PERIODONTIC RETRACTOR, ALL TYPES INSTRUMENT, FILLING, PLASTIC, DENTAL FORCEPS, ENT SPECULUM, ENT FORCEPS HANDLE, SCALPEL CHISEL, BONE, SURGICAL BURNISHER, OPERATIVE SYRINGE, ENT ELEVATOR, SURGICAL, DENTAL SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY MIRROR, MOUTH GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY FORK, TUNING DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY HOLDER, NEEDLE, GASTROENTEROLOGIC CALIPER CHISEL (OSTEOTOME) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Laparoscope, general & plastic surgery TRAY, IMPRESSION, PREFORMED AWL CURETTE ARTICULATORS SPECULUM, VAGINAL, METAL HOOK, SURGICAL, GENERAL & PLASTIC SURGERY GAG, MOUTH ELEVATOR RETRACTOR, SELF-RETAINING REMOVER, CROWN CLAMP, NON-ELECTRICAL KNIFE, SURGICAL FORCEPS, GENERAL & PLASTIC SURGERY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-02-11
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2005-06-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-05-22
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-05-22
KAB	Trocar, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2005-06-08
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2005-06-08
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2019-05-22
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2019-05-22
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2019-05-22
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2005-06-08
EKB	Explorer, Operative	Dental	Class 1	872.4565	2005-06-08
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-06-08
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2005-06-08
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-02-11
HXB	Probe	Orthopedic	Class 1	888.4540	2005-06-08
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2019-05-23
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-05-22
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2005-06-08
EIG	Retractor, All Types	Dental	Class 1	872.4565	2005-06-08
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2005-06-08
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-02-11
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2019-05-22
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2005-06-08
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2005-06-08
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2005-06-08
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2005-06-08
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2005-06-08
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2005-06-08
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-06-08
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2005-06-08
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-06-08
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2005-06-08
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-05-23
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2005-06-08
KTZ	Caliper	Orthopedic	Class 1	888.4150	2005-06-08
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2019-05-22
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-05-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-05-23
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2005-06-08
HWJ	Awl	Orthopedic	Class 1	888.4540	2019-05-22
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2005-06-08
EJP	Articulators	Dental	Class 1	872.3150	2005-06-08
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2005-06-08
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-06-08
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2005-06-08
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2019-05-22
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2019-05-22
EIS	Remover, Crown	Dental	Class 1	872.4565	2005-06-08
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2019-05-22
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-06-08
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-05-22

Official Correspondent

ZESHAN TARIQ

US Agent Details

Johann Scanlan Business: SONTEC INSTRUMENTS INC Email: johann@sontecinstruments.com Phone: (303) 7909411

Related Public Records

Same Entity

T.A. WALTHEM & COMPANY

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
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K894785	Fdt Precision Machine Co., Inc.	SURGICAL CHISEL/OSTEOTOME	1989-08-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003407244. Last updated year: 2026. Please use registration number 3003407244 when referencing this establishment in official correspondence.