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T.A. Walthem & Company: FDA-registered device maker in Sialkot Punjab, Pakistan, 1 510(k) clearance

T.A. Walthem & Company is registered with the FDA (registration 3003407244) in Sialkot Punjab, Pakistan. It lists 70 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 22, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3003407244
Address
Sublime Chowk, Wazirabad RD., Sialkot Punjab, Pakistan, PB 51310
Owner or operator
T.A. WALTHEM & COMPANY (9073915)
Roles
Manufacturer
First device listed
June 8, 2005
Registered through
2026
Brand names listed
ARTICULATORS, AWL, BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL, BURNISHER, OPERATIVE, CALIPER, CARVER, DENTAL AMALGAM, OPERATIVE, CARVER, WAX, DENTAL, CATHETER AND TIP, SUCTION and more

Devices it lists

DeviceProduct codeClassRoleSource
ArticulatorsEJP1Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufactureraccessdata.fda.gov
Burnisher, OperativeEKJ1Manufactureraccessdata.fda.gov
CaliperKTZ1Manufactureraccessdata.fda.gov
Caliper, OphthalmicHOE1Manufactureraccessdata.fda.gov
Carver, Dental Amalgam, OperativeEKH1Manufactureraccessdata.fda.gov
Carver, Wax, DentalEIK1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Chisel (Osteotome)KDG1Manufactureraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Manufactureraccessdata.fda.gov
ClampHXD1Manufactureraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Manufactureraccessdata.fda.gov
Clamp, Rubber DamEEF1Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Curette, EarJYG1Manufactureraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufactureraccessdata.fda.gov
ElevatorHTE1Manufactureraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Manufactureraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Manufactureraccessdata.fda.gov
Explorer, OperativeEKB1Manufactureraccessdata.fda.gov
File, Bone, SurgicalEMI1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Forceps, EntKAE1Manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Manufactureraccessdata.fda.gov
Fork, TuningGWX1Manufactureraccessdata.fda.gov
Gag, MouthKBN1Manufactureraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufactureraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Knife, OrthopedicHTS1Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
MalletHXL1Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
OsteotomeHWM1Manufactureraccessdata.fda.gov
Osteotome, ManualGFI1Manufactureraccessdata.fda.gov
Pliers, SurgicalHTC1Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
Rasp, NasalKBA1Manufactureraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Manufactureraccessdata.fda.gov
Remover, CrownEIS1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Manufactureraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Manufactureraccessdata.fda.gov
Retractor, Self-RetainingFFO1Manufactureraccessdata.fda.gov
RongeurHTX1Manufactureraccessdata.fda.gov
SawHSO1Manufactureraccessdata.fda.gov
Scaler, PeriodonticEMN1Manufactureraccessdata.fda.gov
Scissors, OphthalmicHNF1Manufactureraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufactureraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Manufactureraccessdata.fda.gov
Specula, OphthalmicHNC1Manufactureraccessdata.fda.gov
Speculum, EntEPY1Manufactureraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Manufactureraccessdata.fda.gov
Syringe, EntKCP1Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Trocar, LaryngealKAB1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 22, 2016K152400General & Plastic Surgery InstrumentsGCJSubstantially EquivalentSontec Instruments, Inc.accessdata.fda.gov

Compare with other makers

Updated January 22, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.