FDA Registration
Active
🇺🇸 United States
LYNX Medical NJ
Reg #: 2244478
·
FEI: 1000136269
·
Expires 2026
Products
91
Proprietary Names
121
Establishment Types
1
Classifications
91
Registration Details
- Registration Name
- LYNX Medical NJ
- Registration Number
- 2244478
- FEI Number
- 1000136269
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 19 PARK DR.
- City
- Franklin
- State
- NJ
- ZIP
- 07416
- Country
- US
Owner / Operator
- Firm Name
- LYNX Medical NJ
- Operator Number
- 10094683
- Address
- 19 Park Drive
- City
- Franklin
- State
- NJ
- Postal Code
- 07416
- Country
- US
- Correspondent
- Tara Shuppon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2026-03-26 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2026-01-20 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2026-01-20 |
| Neurosurgical Paddie | HBA | Class 2 | Neurology | No | 2025-12-29 |
| Ophthalmic Femtosecond Laser | OOE | Class 2 | Ophthalmic | No | 2025-12-16 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2026-01-20 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2025-12-16 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2026-03-18 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2026-03-18 |
| Low Energy Direct Current Thermal Ablation System | OAB | Class 2 | General, Plastic Surgery | No | 2026-01-20 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2026-02-19 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2026-02-19 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2026-02-19 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2026-02-19 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2026-02-19 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2026-03-18 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2026-03-18 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2025-12-29 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2026-01-20 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2026-01-20 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2026-01-20 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2026-03-24 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2026-03-24 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-03-24 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2025-12-18 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-03-24 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2025-12-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-01-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2026-03-18 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2026-03-24 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2025-12-16 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-12-16 |
| Prosthesis, Hip, Femoral, Resurfacing | KXA | Class 2 | Orthopedic | No | 2026-03-24 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2026-03-18 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2026-01-20 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2026-03-24 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-12-22 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2026-03-18 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2025-12-29 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2025-12-17 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2026-03-24 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2026-02-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2026-02-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2026-02-19 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2026-02-19 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2026-02-19 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2026-02-19 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2025-12-18 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2026-03-18 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2026-03-24 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2026-01-20 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2026-01-20 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2026-01-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-03-18 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2026-03-24 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2026-03-24 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2025-12-24 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2026-02-19 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2026-02-19 |
| Monitor, Pressure, Intracompartmental | LXC | Class U | Unknown | No | 2025-12-16 |
| Tubing And Tubing/Filter Fits | NVT | Class 1 | Obstetrics/Gynecology | No | 2026-03-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2026-03-24 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2026-03-24 |
| Prosthesis, Wrist, Carpal Trapezium | KYI | Class 2 | Orthopedic | No | 2026-03-24 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2025-12-18 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2026-03-24 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2025-12-16 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2026-01-20 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2026-03-24 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2026-02-04 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2026-02-19 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2026-02-19 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2026-01-20 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2026-02-19 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2026-03-18 |
| Laryngoscope, Non-Rigid | CAL | Class 1 | Anesthesiology | No | 2026-03-18 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2026-03-18 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2025-12-16 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2026-03-18 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2026-03-18 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2026-03-18 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2026-03-18 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2026-03-24 |
| Curtain, Protective, Radiographic | IWQ | Class 1 | Radiology | No | 2025-12-16 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2026-02-04 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2025-12-29 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-03-24 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2026-03-18 |
| Lithotriptor, Ultrasonic | FEO | Class 2 | Gastroenterology, Urology | No | 2026-03-18 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2026-03-18 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2025-12-29 |
Proprietary Names
B-P HIP ACETABULAR BEARING
ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS
Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Neurosurgical Paddie: Telfa
ALLY Adaptive Cataract Treatment System
LAVAGE, JET
HyperSuture
Karl Storz Cutter
Low energy direct current thermal ablation system
Zimmer Trabecular Metal Reverse Shoulder System
Sevin Reverse Shoulder
Karl Storz Supraloop
Karl Storz Cutting Loop
Eye Tray, Comfort Pack
FRN - Pump, infusion FPA - Set, administration, intravascular LGZ - Warmer, thermal, infusion fluid
K-Wires
Ingenix Polyaxial Deformity Screw Kit
Simplifix Hip Fixation System
Suprafoil
Bones Plates and Screws
Gauze/sponge, internal, x-ray detectable: Surgical cotton balls
TRAY, SURGICAL, INSTRUMENT
Karl Storz Adapter Tuohy-Borst
Clover Memory Staple
Derma-Stent
Quicktube Chest Tube Device
NAVITRACK SYSTEM - OS KNEE UNIVERSAL
Sterile Pin Pack
Karl Storz Saw Cutter
B-P HIP FEMORAL RESURFACING CUP W/ BIOCOAT W/ ULTRACOAT
CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
Townly Total Knee
Tomahawk Anchors
Tenodesis Anchors
Eye-Deal Anchors
Dual Anchors
Karl Storz Tubing 6 Pack
Katena Trephine Blades
Barron Radial Vacuum Trephines
Revolution Peripheral Atherectomy System
Quadric Dental Implants
G7 Acetabular System Longevity Highly Crosslinked Polyethylene
Femoral Head
NPWY WOUND DRESSING KIT - LARGE
NPWT WOUND DRESSING KIT - MEDIUM
Karl Storz Electrode
Fasciotome
CARRIER, LIGATURE
Tigon Medical Button System
Set, i.V. Fluid transfer
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Karl Storz Washer
LENSAR Laser System - fs 3D
USMI Scalpel
Great Toe MP Joint
Anatomic Unicompartmental Knee
PSL Hip System
Tourni-Cot Family of Products
Zimmer Persona TM Personalized Knee System
HBS
Bolder Surgical CoolSeal Mini
BioPro Hemi-Edge Toe System
Monitor, Pressure, Intracompartmental
JustRight Sealer
Karl Storz Tubing, Hysteroflator
Tigon Medical Tissue Anchors
Klassic Bipolar Head
Horizon Subtalar
Comprehensive Reverse Shoulder System
Drill Bit
Basal Thumb
Supramid Extra Suture
Supramid Suture
BioPro Tendon Anchor System
Zimmer Persona Personalized Knee System
JustRight Sealer Pediatric
Riza-Ribe Needle
GraNee Needle
ROSA Shoulder System
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
ROSA Partial Knee System
USMI Probes
B-P HIP ACETABULAR FIXATION CUP W/ BIOCOAT W/ ULTRACOAT
Digital Compression Screw
Boomerang Button System
Neurological Stereotaxic Instrument
Zimmer Knee Joint Replacement Prostheses MR Labeling
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Modular Thumb
Neurosurgical Paddie: Americot, Ultracot
Karl Storz Forceps
Persona Partial Knee System
Karl Storz Micro Knife
GO-EZ
OrthAlign Sterile Hip and Knee PinPacks
Modular Thumb TPS
Memory Staple
Karl Storz Suction Valve
Karl Storz Tubing, non-sterile
Cleaner Rotational Thrombectomy System
Karl Storz Cytology Brush
JustRight Stapler & Reload
Allomate Instrument Kit
Rayshield ; X-Drape
RoVo Mechanical Thrombectomy System
Monogram mBos TKA System
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
Sponge, Ophthalmic: Opthalmic Pledget
Accu-Cut Osteotomy Guide
Tara Resurfacing Component
ROSA Knee System
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP
Neurosurgical Paddie: Uniqcot, Ray-Cot, Delicot
Zimmer Persona The Personalized Knee System
Manticore Anchor System
Bipolar Component
Karl Storz Cutting Probe
Karl Storz Knives
Bipolar Head Assembly
Barron Donor Corneal Punches
Barron Vacuum Donor Punches
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)