Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003431869

FEI Number

3003431869

Entity Name

HILBRO INTERNATIONAL (PVT) LIMITED

City/State/Country

SIALKOT Punjab, PK

Establishment Address

12 KM DASKA RD., SIALKOT Punjab 51040, PK

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HILBRO INTERNATIONAL (PVT) LIMITED (Owner Number: 9036420)

Owner / Operator Contact Address

12 KM DASKA RD., --, SIALKOT, PK-NOTA 51040, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Connector, Airway (Extension) Kit, plastic surgery and accessories Hilbro International non-surgical isolation gown RETRACTOR Retractor ENT Hilbro intl drill bit Hook, Surgical, General & Plastic Surgery PLASTIC SURGERY SURGICAL HOOKS HILBRO INTERNATIONAL GENERAL Scissors, Nasal HILBRO INTERNATIONAL NASAL SCISSORS Hilbro Intl periodontic scaler HILBRO INT'L SURGICAL PUNCH Punch, Surgical Bone & Rib Shear, Instruments Cutting Orthopedic Hilbro Int'l Rib/Bone Shear Breathing Tube Support Kit surgical Instrument Disposable HILBRO INTERNATION Pliers, Surgical Tunning Fork Tuning fork CURETTE, UTERINE Forceps, Rubber Dam Clamp Hilbro Intl Rubber dam clamp forcep Hilbro International catheter connector Dissector, Tonsil HILBRO INTERNATION ENT Laryngectomy Tube Dilator Esophageal ENT Clip Iris Retractor CLIP IRIS RETRACTOR Hilbro Intl bone tap CLAMP, RUBBER DAM INSTRUMENT, MICROSURGICAL Forceps, Tooth Extracting, Surgical Hilbro Intl tooth extrctr surg frcp Snare, Nasal HILBRO INTERNATIONAL NASAL SNARE RETRACTOR Retractor, Vaginal HILBRO INTERNATIONAL NASAL CHISEL Chisel, Nasal Cutter, Wire HILBRO INTERNATIONAL WIRE CUTTER Cardiovascular Biopsy Needle Scissors, Surgical General Use Laryngoscope kit Myringotomy Tube Inserter CONNECTOR, URETERAL CATHETER Curette HILBRO INTERNATIONAL CURETTE FORCEPS Forceps - Ophthalmic Hilbro Int'l Probe & Director Probe and Director, Gastro Urology Rectal dilator Dilator Rectal FORCEPS Forceps - Rongeur Spoon, Ophthalmic HILBRO INTERNATION CUFF Spreader KNIFE, ENT HILBRO INTERNATIONAL ENT KNIFE Hilbro International syringe holder adaptor Hilbro Int'l Cardiovascular Fcps Forceps, Cardiovascular Instruments, Surgical Clamp HILBRO INTERNATIONAL CLAMP INSTRUMENT, FILLING, PLASTIC, DENTAL Hilbro Intl surgical bit HILBRO INTERNATIONA Stethoscope, Fetal Forceps, Articulation Paper Hilbro Intl articulating paper frcp Hilbro Intl surgical stripper Scalpel Handle Tray, Surgical, Instruments FORCEPS, BIOPSY, GYNECOLOGICAL Bougie, Urological HILBRO INTERNATIONA Suture removal kit Speculum, ENT HILBRO INTERNATIONAL ENT SPECULUM Retractor all types RETRACTOR Basin, Emesis RETRACTOR Retractor, Ophthalmic Clamps, Surgical, General and Plastic Surgery Forceps Backhaus Towel clamp HILBRO INTERNATIONA Scissors, Umbilical Saw, Nasal HILBRO INTERNATIONAL NASAL SAW HILBRO INTERNATIONAL EAR SCISSOR Scissors, Ear SAW, MANUAL AND ACCESSORIES HILBRO INTERNATION TUBE, EAR SUCTION Bedpan HILBRO INTERNATIONAL NASAL CURETTE Curette, Nasal SPECULUM, ILLUMINATED Speculum Metal Pin Wheel Hilbro International Pin wheel HILBRO INTERNATIONAL EAR CURETTE Curette, Ear HILBRO INT'L SURGICAL Curette, Surgical, General use INSTRUMENT, LIGATURE PASSING AND KNOT TYING Laryngoscope, rigid HILBRO INTERNATION Dilator, Catheter HILBRO INTERNATIONAL BENDER Bender Cannula, ophthalmic HILBRO INTERNATIONAL GENERAL Instrument, Manual, Surgical, General Use HILBRO INTERNATIONAL FIX Dilator, Cervical, Fixed Size GERY HILBRO INT'L SURGICAL GOUGE FOR GEN Gouge, Surgical, General & Plastic Surgery ENT Tonsil Suturing Needle PLIER, ORTHODONTIC Brace, Drill INSTRUMENT, MANUAL, GENERAL OBSTETRIC-GYNECOLOGIC File, Surgical, General and Plastic Surgery HILBRO INTERNATIONAL GENERAL PLASTIC SURGERY SURGICAL FILE HOLDER, NEEDLE Holder, Needle Orthopedic Hilbro Intl surgical metal tongue depressor Rasp, Surgical, General & Plastic Surgery ERY HILBRO INT'L SURGICAL RASP FOR GENE NEEDLE, ASPIRATION AND INJECTION, REUSABLE Hilbro Int'l Medical skin marker Skin Marker OPHTHALMOSCOPE, BATTERY-POWERED Accessory, surgical apparel Hilbro Intl ophthalmic headband mirror Snare, Tonsil HILBRO INTERNATIONAL TONSIL SNARE Hilbro Intl general and plastic surgery mirror Knife, Surgical HILBRO INT'L SURGICAL KNIFE HOOK, GASTRO-UROLOGY Dilator, Lachrymal HILBRO INTERNATIONA HILBRO INTERNATIONAL Chisel, Surgical Manual HILBRO INTERNATIONAL FIBERO Speculum, Vaginal, Metal, Fiberoptic Curette, Adenoid HIBRO INTERNATIONAL ADENOID CURETTE Tray, Surgical HILBRO INTERNATION Hook, Ophthalmic Container, Liquid Medication, Graduated Cannula, Surgical, General & Plastic Surgery HILBRO INT'L SURGICAL CANNULA FOR G URGERY forceps kelly Forceps, Hemostat HILBRO INT'L DISPOSAB Instrument, Surgical, Disposable RETRACTOR Dental Retractor Elevator, Surgical, General and Plastic Surgery HILBRO INT'L SURGICAL ELEVATOR FOR SURGERY Clamp, Uterine HILBRO INTERNATIONAL UTERINE CLAMP HILBRO INTERNATIONAL SCLERAL MARKER Marker, Scleral Gastroenterology Urology Bladder Spreader Osteotome HILBRO INTERNATIONAL OSTEOTOME Hilbro Intl surgical headlight light HILBRO INTERNATIONAL TRACHEAL HOOK Hook, Tracheal Gynecology Intrauterine Hook Remover Spatula, Ophthalmic HILBRO INTERNATIONA HILBRO INTERNATIONAL CONNECT HILBRO INT'L ONE-PIECE SCALPEL Scalpel, one-piece Tray Impression Perforated Ocular Surgery Irrigation Device Hilbro Intl surgical saw blade Speculum, Rectal Forceps, Dressing, Dental Hilbro Intl dental dressing forcep Tracheal suction set Clamps, Cannula Clamp, Eyelid, Ophthalmic HILBRO INTERNATIONAL O Applier, Orthodontic Hilbro Intl trephine Hilbro Intl surgical hemostat Forceps, Hemostat, Surgical RETRACTOR FIBEROPTIC Retractor Fiberoptic HILBRO INTERNATIONAL BONE CALIPER Caliper, Bone Caliper HILBRO INTERNATIONAL Pelvimeter, External Hilbro Intl adenotome Scissors, Collar and Crown Snare, Ear HILBRO INTERNATIONAL EAR SNARE Forceps, for Obstetrical use Hilbro Intl ENT mirror Hilbro Int'l Lister Bandage Scissor NEEDLE, CERCLAGE, GYNECOLOGICAL Specimen Container Otoscope Retractor Non-self retaining RETRACTOR NON-SELF-RETAINING STAPLE, REMOVABLE (SKIN) TUBING, PRESSURE AND ACCESSORIES FORCEPS Forceps Hilbro Intl surgical bur SPECULUM, VAGINAL, NONMETAL, FIBEROPTIC CAST APPLICATION/REMOVAL Instrument, Cast Application / removal / manual Gag, Mouth HILBRO INTERNATIONAL MOUTH GAG Dissector, Surgical, General and Plastic Surgery HILBRO INTERNATIONAL GENERAL PLASTIC SURGERY SURGICAL DISSECTOR Hilbro Intl ENT syringe Surgical Dental Scissors for Tissue Rasp, Nasal HILBRO INTERNATIONAL NASAL RASP Hilbro Intl anesthesiology oropharyngeal airway Emergency obstetrical kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2023-05-19
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2018-02-11
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-07-15
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	1999-02-08
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2015-08-31
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-12-23
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2015-08-31
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-03-14
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2010-08-10
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2026-03-25
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2018-02-11
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-09-19
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2011-02-12
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2018-02-11
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2009-09-16
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-07-15
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2006-09-19
KAC	Tube, Laryngectomy	Ear, Nose, Throat	Class 1	874.4420	2026-03-25
KCF	Dilator, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2011-02-12
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	1999-02-08
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2015-08-31
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2021-12-12
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2018-02-11
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2009-09-16
KBE	Snare, Nasal	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	1999-02-08
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2004-12-23
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2006-09-19
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2026-03-25
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1999-02-08
OGH	Laryngoscope Kit	Anesthesiology	Class 1	868.5540	2018-02-11
JYM	Inserter, Myringotomy Tube	Ear, Nose, Throat	Class 1	874.4420	2026-03-25
EYK	Connector, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2018-02-11
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2004-12-23
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-02-08
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2010-08-10
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2011-02-12
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1999-02-08
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-09-19
CBG	Spreader, Cuff	Anesthesiology	Class 1	868.5760	2026-03-25
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2020-07-15
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2010-08-10
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2006-09-19
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2021-12-12
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2015-08-31
HGN	Stethoscope, Fetal	Obstetrics/Gynecology	Class 1	884.2900	2006-09-19
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2009-09-16
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2015-08-31
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1999-02-08
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-01-07
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2018-02-11
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	2006-09-19
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2018-02-11
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2004-12-23
EIG	Retractor, All Types	Dental	Class 1	872.4565	1999-02-08
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2012-01-07
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-02-08
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-08-31
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2006-09-19
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2006-09-19
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2018-02-11
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
FOB	Bedpan	General Hospital	Class 1	880.6730	2012-01-07
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
FXF	Speculum, Illuminated	General, Plastic Surgery	Class 1	878.1800	2021-12-12
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1999-02-08
GWY	Pinwheel	Neurology	Class 1	882.1750	2010-08-10
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-03-14
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2021-12-12
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2003-07-29
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2006-09-19
HXW	Bender	Orthopedic	Class 1	888.4540	2006-09-19
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-02-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-09-19
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2006-09-19
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-03-14
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2026-03-25
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2018-02-11
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2011-02-12
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2018-02-11
GEO	File, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-09-19
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	1999-02-08
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2015-08-31
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-03-14
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2018-02-11
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2009-07-30
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2021-12-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-07-15
HKF	Mirror, Headband, Ophthalmic	Ophthalmic	Class 1	886.1500	2015-08-31
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-08-31
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-03-14
FHB	Hook, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2018-02-11
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2006-09-19
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2006-09-19
HDG	Speculum, Vaginal, Metal, Fiberoptic	Obstetrics/Gynecology	Class 1	884.4520	2006-09-19
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-01-07
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-09-19
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2012-01-07
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-03-14
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2009-08-31
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-03-14
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	1999-02-08
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-03-14
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2006-09-19
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2006-09-19
FHK	Spreader, Bladder Neck	Gastroenterology, Urology	Class 1	876.4730	2026-03-25
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2006-09-19
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2015-08-31
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2006-09-19
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2026-05-26
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-09-19
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2004-12-23
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2007-03-14
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2011-02-12
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2026-03-25
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2015-08-31
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2001-01-19
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2009-09-16
OFS	Tracheal Suction Set	Anesthesiology	Class 1	868.6810	2018-02-11
FKC	Clamp, Cannula	Gastroenterology, Urology	Class 1	876.5540	2011-02-12
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-09-19
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2018-02-11
HWK	Trephine	Orthopedic	Class 1	888.4540	2015-08-31
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2009-09-16
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	1999-02-08
KTZ	Caliper	Orthopedic	Class 1	888.4150	2006-10-04
HER	Pelvimeter, External	Obstetrics/Gynecology	Class 1	884.4520	2006-09-19
KBH	Adenotome	Ear, Nose, Throat	Class 1	874.4420	2015-08-31
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2011-02-12
JZD	Snare, Ear	Ear, Nose, Throat	Class 1	874.4420	2006-09-19
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2025-09-27
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2015-08-31
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2009-09-08
HDH	Needle, Cerclage, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2018-02-11
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2026-03-25
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2011-02-12
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1999-02-08
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2018-02-11
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2023-11-29
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1999-02-08
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2015-08-31
HIC	Speculum, Vaginal, Nonmetal, Fiberoptic	Obstetrics/Gynecology	Class 2	884.4530	2021-12-12
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	1999-02-08
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-09-19
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2015-08-31
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2026-03-25
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2004-12-23
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2015-08-31
OKU	Emergency Obstetrical Kit	Obstetrics/Gynecology	Class 1	884.4520	2018-02-11

Official Correspondent

No official correspondent registered.

US Agent Details

Omer Ahmed Business: Technicality INC. Email: omer22m@gmail.com Phone: (630) 2795000

Related Public Records

Same Entity

HILBRO INTERNATIONAL (PVT) LIMITED

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
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

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Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003431869. Last updated year: 2026. Please use registration number 3003431869 when referencing this establishment in official correspondence.