Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007137643

FEI Number

3007137643

Entity Name

Hayden Medical Inc

City/State/Country

Valencia, CA, US

Establishment Address

26074 Avenue Hall Ste 2, Valencia, CA 91355, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Hayden Medical (Owner Number: 10026720)

Owner / Operator Contact Address

26074 Avenue Hall, Unit 2, Valencia, CA 91355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scalpel Handle Ring Pessary Gellhorn Pessary Oval Pessary Cube Pessary Dish Incontinence Pessary Donut Pessary 3-Play Mask Barron Areola Marker; D'Assumpcao Flap Marker; Freeman Areola Marker; Lockwood Flap Marker; Pitanguy Flap Demarcator; Umbilical Marker Varady Phlebectomy Extractor Hook Wilder Lachrimal Dilator Scalpel Blade Joseph Rasp Maltz Nasal Rasp Aufricht Glabela Rasp Lewis (Joseph) Rasp Peet-Cottle Nasal Rasp Dorsal Nasal Rasp Fomon Nasal Rasp Cottle (Parkes) Nasal Rasp Fiber Optic Light Cable Fisher Tonsil Knife Biopsy Punch Endo-Plastic Scope 7" (175mm), 4mm diameter, 30° Jacobson Microvascular Needle Holder Aufricht Retractor, Converse Nasal Retractor; Cottle Nasal Speculum; Gruber Ear Speculum; Killian Nasal Speculum; Vienna Nasal Speculum Lothrop Uvula Retractor Limbal Relaxing Incision LRI Marker Bores Two-Ray Meridian Marker Koch Mendez Fixation Ring Hoffer Optical Marker Mendez Degree Gauge Henderson Beveled Degree Gauge Bores Plain Optical Zone Marker Alignment Gauge Marker Toric IOL Marker Toric Axis Marker Bone Tamp Grossman Areola Marker Thorpe Caliper Halpern Breast Caliper Ackermann Areola Marker Chang Areola Marker McKissock Breast Caliper Freeman Areola Marker Walden Breast Marker McKissock (Collyer) Caliper Jameson Caliper Transfer hub Rosen Pick Castroviejo Caliper Needle Extender Iowa Trumpet Pudenal Needle Guide Martel Flap Grasping Forceps Backhaus Towel Clamp Masterson Hysterectomy Clamp Lorna (Edna) Towel Clamp D'Assumpcao Flap Marker Marten Flap Marker MD Anderson Clamp Jones Towel Clamp Krobach Tissue Clamp Lockwood Abdominal Demarcator Pitanguy Flap Demarcator McGivney Hemorrhoidal Ligator Forceps Caplan Nasal Scissors Knight Nasal Scissors Giunta Nasal Scissors Joseph Nasal Scissors Cottle Dorsal Scissors Fomon Dorsal Nasal Scissors Hysterectomy Clamps; Hysterectomy Forceps; Tenaculum; Uterosacral Clamp, Z-Best Clamp Tonsil Needle University of Minnesota Cheek Retractor Slip Joint Adjustable Pliers Emesis Basin; Sponge Bowl Knot Pusher Nail & Bone Rasp Light Cable Adapter Surgical Tray Fomon Nasal Knife Harrington Retractor with Fiberoptic Light; Heaney Retractor with Fiberoptic Light; Breisky Retractor with Fiberoptic Light; Deaver Retractor with Fiberoptic Light; Ferriera Endo Retractor; Killian Retractor with Fiberoptic Light; St. Marks Retractor with Fiberoptic Light; Tebbetts Endo Retractor; Wieder Retractor with Fiberoptic Light; Wiley Retractor with Fiberoptic Light Aufricht Retractor with Fiberoptic Light; Biggs Retractor with Fiberoptic Light; Piffard Dermal Curette Martini-Hayden Curette Fox Dermal Curette Williger-Hayden Curette Meyhoefer Chalazion Curette Hemorrhage Occluder Pin Side Biting Antrum Punch Ballenger Swivel Knife, Joseph Nasal Knife Ostrum Antrum Punch Biopsy Forceps Smith-Petersen Osteotome Cottle Osteotome; Cinelli Osteotome; Hayden Osteotome; Hibbs Osteotome; Hoke Osteotome; Lambotte Osteotome; Neivert Osteotome; Parkes Lateral Osteotome; Rubin Osteotome; Sheehan Osteotome; Silver Osteotome; Buck Ear Curette Dingman Otobraders Billeau Flexible Ear Loop House Strut Caliper Iodine Cup Measuring Cup Medicine Cup Adair Tenaculum Finger Ring Cutter Gimbel Irrigation Cannula Knolle AC Cannula McIntyre Anterior Chamber Cannula Alio Lasik Irrigation Cannula Akahoshi II Hydrodissection Cannula Wiles Hydrodissection Cannula Bishop-Harmon Caannula McIntyre-Binkhorst Cannula Capsular Fornix Hydrodissection Cannula Chang Nucleus Hydrodissection Cannula Scheie Anterior Chamber Cannula Gimbel Hydrodissection Cannula Lewicky Chamber Maintainer Air Injection Cannula Gross Sub-Tenon's Anesthesia Cannula Lewis Lens Loop Wilder Lens Loop Machat/Fukasaku PRK/LASIK Spatula Pratt Rectal Speculum; Sawyer Rectal Retractor; Smith-Buie Anal Retractor Alan Parkes Anal Retractor; Boddenhammer Rectal Retractor; Brinkerhoff Rectal Retractor; Chelsea-Eaton Rectal Specula; Tri-port Cannula Infusion Cannula; Garden Spray Cannula; Hasson Cannula; Lipo Cannula, Mercedes Cannula; Reinjection Cannula; Forceps, Needle Holders, Retractors, Scissors, Hemostats,Markers Yankauer Suction Tube Sinus Suction Tube Poole Suction Tube Andrews-Pynchon Suction Tube Mixter Hemostatic Forceps; O'Brien Fixation Forceps; Ochsner Hemostatic Forceps; Oschner (Kocher) Forceps; Tissue Forceps; Tubingen Tying Forceps; Virtus Splinter Forceps; Weil Blakesley Forceps; ; Adson-DeBakey Forceps; Allis Forceps; Allis-Adair Forceps; Babcock Forceps; Baby Allis Forceps; Desjardin Forceps; Doyen Intestinal Forceps; Dressing Forceps; Feilchenfeld Splinter Forceps; Ferris-Smith Tissue Forcep Blepharoplasty Forceps; Bonney Tissue Forceps; Bonnie Forceps; Burke Biopsy Forceps; Carmalt Splinter Forceps; Crile-Rankin Hemostatic Forceps; Cushing Bayonet Tissue Forceps; Cushing Dressing Forceps; DeBakey Tissue Forceps; Green Fixation Forceps; Griffith Brown Forceps; Halsted Mosquito Artery Forceps; Hansen D & E Forceps; Hartman Alligator Forceps; Hartman Mosquito Forceps; Hartman Cup Forceps; Iris Dressing Forceps; Iris Tissue Forceps; Jeweler Forceps; Jones Clip Towel Forceps; Judd-Allis Forceps; Kelly Hemostatic Forceps; Potts-Smith Tissue Forceps; Pratt Hemostat Forceps; Pratt T-Shape Tissue Grasping Forceps; Putterman Forceps; McCullough Utility Forceps; McGivney Hemorrhoid Grasping Forceps; Microsurgery Tissue Forceps; Mixter Forceps; Adson Brown Forceps; Adson Dressing Forceps; Adson Forceps; Adson Tissue Forceps; Adson-Brown Tissue Forceps; Wilde (Blakesley) Ethmoid Forceps; Wilde Ear Forceps Kocher Hemostatic Forceps; Lahey Forceps; Lane Tissue Forceps; Littauer Cilia Forceps; Lucae Dressing Forceps; Foerster Sponge Forceps; Gemini Forceps; Gerald Tissue Forceps; Graefe Tissue Forceps; Randall Stone Forceps; Rochester Pean Forceps; Rochester-Carmalt Forceps; Rubin Strut Forceps, Barraquer (Kurth) Forcep; Barron Alligator Seizing Forceps; Bengolea Hemostatic Forceps; Bishop-Harmon Forceps; Oehler Forceps; Pennington Tissue Forceps; Plain Splinter Forceps; Potts-Smith Dressing Forceps; Russian Tissue Forceps; Schroeder Grasping Forceps; Semken Dressing Forceps; Semken Tissue Forceps; Suturing Forceps; Swiss Cilia Forceps; Takahashi Forceps; Taylor Dressing Forceps; Taylor Tissue Forceps; Thomas-Allis Forceps; Carroll Tendon Forceps; Castroviejo Suturing Forcep; Clark Artery Forceps; Colibri Forceps; Crile Hemostatic Forceps; Medical Endoscope Camera System Martin's Arm Retractor Kleinert-Kutz Hook; Lahey Skin Hook; Millard Hook; Suture Retrieval Hook; Tyrell (Iris) Skin Hook Cottle Hook; Double Thumb Hook; Frazier Dura Hook; Guthrie Hook; IUD Hook; Joseph Skin Hook; Kilner Hook; Sexton Ear Knife Surgical Stool, Doctors Stool LLETZ Loop Electrode Baron Suction Tube Frazier Ferguson Suction Tube Sinus Suction Tube Schuknecht Suction Tube Bone File White Tonsil Seizing Forceps Jackson Style 2mm Cup Biopsy Forceps House Alligator Ear Forceps Hartman-Herzfeld Forceps Rubin Alar (Gunter) Morselizer Heyman-Knight Forceps Hartman-Noyes Forceps Gruenwald (Jansen) Dressing Forceps Takahashi Ethmoid Forceps Eve Tonsil Snare Backhaus Towel Clamp; Cottle Clamp; Desmarres Clamp; Krobach Tissue Clamps; Lorna (Edna) Towel Clamp; Kleinert-Kutz (Ruskin) Forceps Magill Endotracheal Spatula & Packer Probe & Packer SMOKE SHARK 18-HOUR FILTER Iris Hook Pliers and Wire Cutter Mayo Tray Sterilization Basket Solution Basin Instrument Tray Murphy-Lane Bone Skid Baby Iris Scissors; Baby Lexer Scissors; Baby Metzenbaum Scissors; Cottle Scissors; Freeman Facelift Scissors; Mayo Scissors; Mayo-Noble Scissors; Mayo-Stille Scissors; Metzenbaum Scissors; Nelson Scissors; Wilkinson Facelift Scissors; Wilmer Scissors; Wire Cutting Scissors Freeman-Kaye Facelift Scissors; Goldman Fox Scissors; Gorney Facelift Scissors; Gradle Scissors; Iris Scissors; LaGrange Scissors; Lister Bandage Scissors; Littler Scissors; Martin Scissors; Mayo Dissecting Scissors; Spencer Stitch Removal Scissors; Stevens Tenotomy Scissors; Strabismus Scissors; Utility Bandage Scissors; Operating Scissors; Peck-Joseph Scissors; Ragnell Scissors; Rees Facelift Scissors; Reynolds Tenotomy Scissors; MACINTOSH MILLER Tischler Burke Biopsy Forceps; Tischler Coppelson Biopsy Forceps; Tischler Biopsy Forceps Schubert Biopsy Forceps; Tischler Biopsy Forceps; Tischler Kevorkian Biopsy Forceps; Wittner Biopsy Forceps Baby Tischler Biopsy Forceps; Berger Biopsy Forceps; Douay Biopsy Forceps; Eppendorf Biopsy Forceps Tischler Morgan Biopsy Forceps; Van Doren Biopsy Forceps; Wittner Biopsy Forceps; Yeoman Biopsy Forceps Burke Biopsy Forceps; Eppendorfer Biopsy Forceps; Kevorkian Biopsy Forceps; Mini Tischler Biopsy Forceps Faure Biopsy Forceps; Kevorkian Pacific Biopsy Forceps; Kevorkian Tischler Biopsy Forceps Kevorkian Young Biopsy Forceps; Mini-Townsend Biopsy Forceps; Morgan Biopsy Forceps; Oval Biopsy Forceps Thoms-Gaylor Biopsy Forceps; Tischler Apex Biopsy Forceps; Tischler Baggish Biopsy Forceps Roto Handle Biopsy Forceps; Schubert Biopsy Forceps; Schumacher Biopsy Forceps; Sullivan Biopsy Forceps Henning Cast Spreader Bailey-Gibbon Rib Contractor Laparoscopic Scissors Laparoscopic Grasper Full HD Camera System w/ Integrated Monitor and Light Source, 1080p resolution w/ touchscreen Kelly Forceps Hartman Mosquito Forceps Kocher Forceps Rochester (Pean) Forceps Halsted Mosquito Forceps Crile Forceps Eye Shield, Eye Goggles Probe and Excavator Ferguson Gall Stone Scoop Sponge Bowl Williams Lacrimal Probes Bowman Lacrimal Probes Virchow Skull Breaker Ballenger V-Shaped Chisel Shaper Elevator; Williger Elevator Boies Elevator; Cottle Elevator; Freer Elevator; Doyen Elevator; Gorney Elevator; Joseph Elevator; Key Elevator; Kleinert-Kutz Elevator; McCollugh Elevator; McKenty Elevator; Obwegeser Elevator; Sachs Elevator; Sayre Elevator; Flexible Silicone Vaginal Dilator Scissors, Forceps, Graspers, Retractors, Needle Holders Vu-Max Speculum; Walton Speculum; Weisman Speculum; Weisman-Graves Speculum O'Sullivan-O'Connor Speculum; Pederson Speculum; Scherback Speculum; Sims Speculum; Steiner Speculum; Auvard Speculum; Collin Vaginal Speculum; Cusco Vaginal Speculum; Graves Speculum; Moore-Graves Speculum; Gerzog Mallet; Hayden Mallet; Lucae Mallet; Mead Mallet; Miyazaki Mallet Mueller Putterman Clamp Lambotte Osteotome Sheehan Osteotome Neivert-Anderson Osteotome Cinelli Osteotome Rubin Dorsal Osteotome Silver Osteotome Cottle Osteotome Desmarres Retractor Knapp Retractor Jaeger Lid Plate Rollet Retractor Smoke Evac Corrugated Tubing Barnhill Adenoid Curette Micro Osteotome Gruber Columella Retractor with Weight Desmarres Weighted Nasal Retractor Dittel Van Buren McCrea Lefort Goodwin Jewett Walther Sheen Grid Andrews-Pinchon SuctionTube Baron Suction Tube; Frazier Suction Tube; Poole Aspiration Tube; Yankauer Tube Bellucci Micro Ear Scissors LED Light Source Castroviejo Caliper; Halpern Breast Caliper; Jameson Caliper; McKissock Breast Caliper; Thorpe Caliper, Ruler Preservation Rhinoplasty Saw Joseph Nasal Saw IUD Extractor Simpson Obstetrical Forceps Weiner Antrum Rasp Koch Stop and Chop Manipulator Kuglen Iris Hook Vukich ICL/Toric Lens Manipulator Nichamin Triple Chopper Green Muscle Hook Graefe Strabismus Hook Jameson Muscle Hook Stevens Tenotomy Hook Thornton Fixation Ring Lester IOL Manipulator Batlle ICL Manipulator Guthrie (Iris) Hook Micro Osher/Malyugin Seibel Ambidextrous Chopper Deitz ICL Manipulator Sinskey Lens Manipulating Hook Watson dermatome Hank Dilator; Hegar Dilator; Os Finder Dilator; Pratt Dilator; Simpson Dilator; Sims Dilator Keyes Punch Ophthalmic Forceps Guttman Retractor; Lateral Vaginal Retractor; Redundant Wall Retractor Halle Ethmoid Curette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2020-05-23
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2022-07-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-23
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2020-05-23
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	Class 1	878.4800	2023-12-04
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2022-07-15
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2020-05-23
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-07-14
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2022-07-15
KBQ	Knife, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2023-03-08
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2022-07-15
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2026-04-28
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2023-03-06
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2020-05-23
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2023-03-08
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2022-07-15
HXG	Tamp	Orthopedic	Class 1	888.4540	2023-03-09
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-07-14
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2023-03-10
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2023-03-06
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-15
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-07-14
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-07-14
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2023-03-09
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-05-23
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2022-07-15
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2018-07-16
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2023-03-08
EIG	Retractor, All Types	Dental	Class 1	872.4565	2023-03-08
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-03-09
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2018-07-16
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2020-05-23
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2022-07-15
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2022-07-15
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-05-23
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2022-07-15
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2023-03-08
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2018-07-16
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2022-07-15
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2022-07-14
KBS	Punch, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2023-03-10
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-05-23
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	2023-03-06
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2023-03-06
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2020-05-23
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-07-15
JYZ	Rod, Measuring Ear	Ear, Nose, Throat	Class 1	874.4420	2023-03-06
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2022-07-15
PUA	Tenaculum, Uterine, Exempt	Obstetrics/Gynecology	Class 2	884.4530	2022-08-10
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2022-07-13
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-15
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-15
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-15
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2020-05-23
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-05-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-05-23
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2012-06-12
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2022-07-15
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-07-16
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2024-04-01
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2022-07-14
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-05-23
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2023-03-06
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2020-05-23
ODR	Electrosurgical Patient Return Electrode	General, Plastic Surgery	Class 2	878.4400	2022-08-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-08-31
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2022-07-15
GEO	File, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-07-14
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-07-15
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2023-03-08
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2022-07-15
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2020-05-23
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2022-07-15
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2023-03-08
HXR	Spatula, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2022-07-13
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2022-08-31
HDE	Hook, Fibroid, Gynecological	Obstetrics/Gynecology	Class 1	884.4520	2023-03-09
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2023-03-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-07-13
HWO	Skid, Bone	Orthopedic	Class 1	888.4540	2023-03-09
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-07-16
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2022-07-13
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2018-07-16
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2023-03-09
FZR	Contractor, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-03-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-07-15
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2024-04-01
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2022-07-15
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-05-23
HXB	Probe	Orthopedic	Class 1	888.4540	2022-07-15
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2023-03-06
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2022-07-15
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2022-07-15
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2022-07-15
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-05-23
HDX	Dilator, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2022-09-08
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2010-08-23
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2018-07-16
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2020-05-23
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-15
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2022-07-15
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-15
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2022-07-14
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2022-07-15
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2022-07-15
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	2022-07-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-07-15
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2020-05-23
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2023-03-06
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2022-07-15
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2020-05-23
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2022-07-15
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2022-07-15
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2023-03-10
JYY	Rasp, Ear	Ear, Nose, Throat	Class 1	874.4420	2023-03-08
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-15
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2023-03-10
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2018-07-16
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-07-15
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-05-23
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2018-07-16
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2023-03-08

Official Correspondent

Scott Clelland

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hayden Medical

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
K933654	Johnson & Johnson Medical, Inc.	BLADDER NECK SUPPORT PROTHESIS FITTING KIT	1995-05-04
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0001-2021	N/A	2	Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007137643. Last updated year: 2026. Please use registration number 3007137643 when referencing this establishment in official correspondence.