PHOENIX INSTRUMENTS, INC.

FDA Device Registration & Listing · Lisle, IL, US · Registration 1421879

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1421879
FEI Number
1000115048
Entity Name
PHOENIX INSTRUMENTS, INC.
City/State/Country
Lisle, IL, US
Establishment Address
4985 Varsity Dr, Lisle, IL 60532, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PHOENIX INSTRUMENTS, INC. (Owner Number: 9001729)
Owner / Operator Contact Address
4985 Varsity Drive, Lisle, IL 60532, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Support, Patient Position PROBE, PERIODONTIC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HDE Hook, Fibroid, Gynecological Obstetrics/Gynecology Class 1 884.4520 2013-02-01
FXE Speculum, Non-Illuminated General, Plastic Surgery Class 1 878.1800 2019-08-23
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-31
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-01
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 2013-02-01
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2013-02-01
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-31
HXB Probe Orthopedic Class 1 888.4540 2020-11-06
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2020-11-06
HGC Clamp, Uterine Obstetrics/Gynecology Class 1 884.4520 2013-02-01
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2013-02-01
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2019-08-26
FFP Dilator, Rectal Gastroenterology, Urology Class 1 876.5450 2013-01-31
HWI Corkscrew Orthopedic Class 1 888.4540 2019-08-23
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2013-01-30
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2013-02-01
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2013-02-06
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2019-08-23
EIR Scissors, Collar And Crown Dental Class 1 872.4565 2013-01-30
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2013-01-30
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-02
HTX Rongeur Orthopedic Class 1 888.4540 2013-02-01
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2013-02-01
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2013-02-02
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2013-02-01
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2013-02-01
JET Pick, Massaging Dental Class 1 872.6650 2019-08-23
EJY Pliers, Operative Dental Class 1 872.4565 2019-08-22
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 2019-08-22
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2013-02-01
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2013-01-31
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-01-31
EKB Explorer, Operative Dental Class 1 872.4565 2013-02-06
HER Pelvimeter, External Obstetrics/Gynecology Class 1 884.4520 2013-02-01
IRA Hand, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2019-08-26
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2013-02-01
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2013-02-01
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2020-11-06
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 2013-02-06
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-31
FHB Hook, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2013-01-31
HNA Spud, Ophthalmic Ophthalmic Class 1 886.4350 2019-08-23
FHL Scoop Gastroenterology, Urology Class 1 876.4730 2019-08-23
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 2013-02-06
GWX Fork, Tuning Neurology Class 1 882.1525 2013-01-31
EKE Curette, Operative Dental Class 1 872.4565 2013-02-06
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2013-02-01
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-31
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2013-01-31
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2020-11-11
HTW Bit, Drill Orthopedic Class 1 888.4540 2019-08-23
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2019-10-08
KAQ Gouge, Nasal, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
HSO Saw General, Plastic Surgery Class 1 878.4800 2013-02-01
HTE Elevator General, Plastic Surgery Class 1 878.4800 2013-02-06
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 2013-02-01
HWK Trephine Orthopedic Class 1 888.4540 2013-02-01
JYJ Gauge, Measuring Ear, Nose, Throat Class 1 874.4420 2020-11-06
HXL Mallet General, Plastic Surgery Class 1 878.4800 2019-08-23
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2013-02-01
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2013-02-01
HDM Packer, Uterine Obstetrics/Gynecology Class 1 884.4520 2013-02-06
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 2013-02-01
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2019-08-23
JYE Chisel, Middle-Ear Ear, Nose, Throat Class 1 874.4420 2019-08-23
EKC Excavator, Dental, Operative Dental Class 1 872.4565 2013-02-06
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-02-02
HBD Handpiece (Brace), Drill Neurology Class 1 882.4325 2013-02-01
EIK Carver, Wax, Dental Dental Class 1 872.4565 2019-08-22
NNR Block, Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2013-02-02
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2020-11-06
KBH Adenotome Ear, Nose, Throat Class 1 874.4420 2013-02-01
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type Obstetrics/Gynecology Class 1 884.4530 2013-02-01
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 2019-08-23
FNY Basin, Emesis General Hospital Class 1 880.6730 2013-01-31
JYC Cannula, Ear General, Plastic Surgery Class 1 878.4800 2020-11-06
KCF Dilator, Esophageal, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
HXY Brace, Drill Orthopedic Class 1 888.4540 2019-08-23
HTO Reamer Orthopedic Class 1 888.4540 2019-08-23
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2013-01-31
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2013-02-01
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 2013-02-01
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-01
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2020-11-09
FTX Mirror, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-06
JYF Clamp, Ossicle Holding Ear, Nose, Throat Class 1 874.4420 2019-08-23
EMI File, Bone, Surgical Dental Class 1 872.4565 2020-11-06
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2013-01-31
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2013-01-31
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2013-02-01
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-31
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2013-02-06
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2013-02-01
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2013-01-30
HOF Burr, Corneal, Manual Ophthalmic Class 1 886.4350 2020-11-06
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2020-11-06
FGN Retractor, Non-Self-Retaining Gastroenterology, Urology Class 1 876.4730 2013-01-31
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-01-31
JEX Plier, Orthodontic Dental Class 1 872.4565 2013-02-06
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 2013-02-01
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2013-02-06
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2020-11-06
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2013-01-31
KTZ Caliper Orthopedic Class 1 888.4150 2013-02-02
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2019-08-23
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2020-11-18
HTP File Orthopedic Class 1 888.4540 2013-02-01
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2013-01-30
HCD Cannula, Ventricular Neurology Class 1 882.4060 2019-08-23
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-01
KBS Punch, Adenoid Ear, Nose, Throat Class 1 874.4420 2013-02-01
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-06
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2013-02-01
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2013-02-06
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2013-01-31
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2013-01-31
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-11-11
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2013-01-31
EXX Probe, Rectal, Non-Powered Gastroenterology, Urology Class 1 876.4730 2013-01-30
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2013-01-30
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-01-31
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2020-11-06
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2020-11-11
JYH Excavator, Ear Ear, Nose, Throat Class 1 874.4420 2020-11-06
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2020-11-09
EJG Forceps, Rubber Dam Clamp Dental Class 1 872.6300 2013-02-06
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 2013-02-01
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2013-02-01
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2013-02-02
EMR File, Periodontic Dental Class 1 872.4565 2020-11-06
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-01
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2013-02-01
KOH Instrument, Manual, General Obstetric-Gynecologic Obstetrics/Gynecology Class 1 884.4520 2013-02-02
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-31
FBX Sound, Urethral, Metal Or Plastic Gastroenterology, Urology Class 1 876.5520 2013-01-30
EEF Clamp, Rubber Dam Dental Class 1 872.6300 2013-02-06
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-01
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2020-11-06
BWB Forceps, Tube Introduction Anesthesiology Class 1 868.5780 2013-01-30
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2020-11-06
EYA Stylet, Ureteral Gastroenterology, Urology Class 1 876.5130 2013-01-30
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 2020-11-06
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 2013-02-01
HWJ Awl Orthopedic Class 1 888.4540 2013-02-01
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2013-02-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-11-11
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2013-02-01
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2019-08-22
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2013-02-01
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-11-11
JYK Holder, Ear Speculum General, Plastic Surgery Class 1 878.1800 2020-11-06
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-01
HNP Introducer, Sphere Ophthalmic Class 1 886.4350 2013-02-01
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-02-02
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2019-08-23
JYP Knife, Myringotomy Ear, Nose, Throat Class 1 874.4420 2013-02-01
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2013-01-30
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2013-02-01
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2013-02-01
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2020-11-11
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2019-08-22
OHW Burr, Corneal, Battery Powered, Rust Ring Removal Ophthalmic Class 1 886.4070 2020-11-09
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2013-01-31
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-06
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2013-02-01
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 2013-02-01
HMR Marker, Ocular Ophthalmic Class 1 886.4570 2013-02-01
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 2013-02-01
KAR Irrigator, Sinus Ear, Nose, Throat Class 1 874.4420 2013-02-01
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2013-02-01
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2013-01-31
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2013-02-01
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2013-01-30
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2013-02-02
KQW Goniometer, Nonpowered Orthopedic Class 1 888.1520 2019-08-23
KAC Tube, Laryngectomy Ear, Nose, Throat Class 1 874.4420 2020-11-09
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2020-09-23
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-31
EAX Mirror, Mouth Dental Class 1 872.4565 2020-11-06
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2013-02-01
HXG Tamp Orthopedic Class 1 888.4540 2013-02-01
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2013-01-31
HNE Snare, Enucleating Ophthalmic Class 1 886.4350 2013-02-01
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2013-02-01
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 2013-02-06
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2013-02-01
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2013-01-31
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2013-02-01
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 2013-02-01
HNK Probe, Trabeculotomy Ophthalmic Class 1 886.4350 2019-08-23
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2013-02-01
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-02
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-02-02
HXD Clamp General, Plastic Surgery Class 1 878.4800 2013-02-01
EQH Source, Carrier, Fiberoptic Light Ear, Nose, Throat Class 1 874.4350 2019-08-22
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-01
FNS Ring Cutter General Hospital Class 1 880.6200 2013-01-31
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2013-02-06
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
EKJ Burnisher, Operative Dental Class 1 872.4565 2019-08-22
KBR Needle, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 2013-02-01
HTF Curette General, Plastic Surgery Class 1 878.4800 2020-11-06
MXY Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal Ophthalmic Class 1 886.4350 2019-08-23
EIX Probe, Periodontic Dental Class 1 872.4565 2019-08-22
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2013-01-31
HTD Forceps General, Plastic Surgery Class 1 878.4800 2013-02-01
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2019-08-23
HDJ Scissors, Umbilical Obstetrics/Gynecology Class 1 884.4520 2013-02-01
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2013-02-06
HWA Impactor Orthopedic Class 1 888.4540 2013-02-01

Official Correspondent

ARSHAD JAVED

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PHOENIX INSTRUMENTS, INC.
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
K914226 E.I. Dupont DE Nemours & Co., Inc. ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK 1991-11-19
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28
K894785 Fdt Precision Machine Co., Inc. SURGICAL CHISEL/OSTEOTOME 1989-08-18
K821629 Moyco Industries, Inc. FIXIDENT 1982-06-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
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-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-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1421879. Last updated year: 2026. Please use registration number 1421879 when referencing this establishment in official correspondence.
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