FDA Registration
Active
🇺🇸 United States
LYNX Medical Pennsylvania
Reg #: 2528981
·
FEI: 2528981
·
Expires 2026
Products
109
Proprietary Names
195
Establishment Types
1
Classifications
108
Registration Details
- Registration Name
- LYNX Medical Pennsylvania
- Registration Number
- 2528981
- FEI Number
- 2528981
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2205 E 33rd St
- City
- ERIE
- State
- PA
- ZIP
- 16510
- Country
- US
Owner / Operator
- Firm Name
- LYNX Medical Pennsylvania
- Operator Number
- 10094665
- Address
- 2205 East 33rd St
- City
- Erie
- State
- PA
- Postal Code
- 16510
- Country
- US
- Correspondent
- Heather Parker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2025-12-15 |
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2025-12-15 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2025-12-15 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2025-12-15 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2025-12-15 |
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2025-12-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-12-15 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2025-12-15 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2025-12-15 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2025-12-15 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-12-15 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2025-12-15 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2025-12-15 |
| Dislodger, Stone, Flexible | FGO | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2025-12-15 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2025-12-15 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2025-12-15 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-12-15 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2025-12-15 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-12-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2025-12-15 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2025-12-15 |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2025-12-15 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2025-12-15 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2025-12-15 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2025-12-15 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2025-12-15 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2026-04-30 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-12-15 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2025-12-15 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2025-12-15 |
| Culdoscope (And Accessories) | HEW | Class 2 | Obstetrics/Gynecology | No | 2025-12-15 |
| Catheter, Suprapubic (And Accessories) | KOB | Class 2 | Gastroenterology, Urology | No | 2026-04-30 |
| Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | ODD | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | Class 2 | Hematology | No | 2025-12-15 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2025-12-15 |
| Catheter, Septostomy | DXF | Class 2 | Cardiovascular | No | 2025-12-15 |
| Temporary Non-Roller Type Left Heart Support Blood Pump | OZD | Class 3 | Unknown | No | 2025-12-15 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2025-12-15 |
| System, Imaging, Gastrointestinal, Wireless, Capsule | NEZ | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2025-12-15 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2025-12-15 |
| Balloon Aortic Valvuloplasty | OZT | Class 2 | Cardiovascular | No | 2025-12-15 |
| Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | NVM | Class 2 | Cardiovascular | No | 2025-12-15 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | OMZ | Class 2 | Cardiovascular | No | 2025-12-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | NJL | Class 3 | Unknown | No | 2025-12-15 |
| Aortic Stent | PNF | Class 3 | Unknown | No | 2025-12-15 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2025-12-15 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2026-04-30 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2025-12-15 |
| Lithotriptor, Ultrasonic | FEO | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Pulmonary Valve Prosthesis Percutaneously Delivered | NPV | Class f | Unknown | No | 2025-12-15 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2025-12-15 |
| Absorbable Collagen Hemostatic Agent With Thrombin | PMX | Class 3 | General, Plastic Surgery | No | 2025-12-15 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Irrigator, Ostomy | EXD | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2025-12-15 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Tube, Gastro-Enterostomy | KGC | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Bone Grafting Material, Human Source | NUN | Class 2 | Dental | No | 2025-12-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2025-12-15 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2025-12-15 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2025-12-15 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2025-12-15 |
| Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation | OCM | Class 3 | Unknown | No | 2025-12-15 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-12-15 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2025-12-15 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2025-12-15 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2025-12-15 |
| Dilator, Esophageal | KNQ | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| PBL | No | 2025-12-15 | |||
| Marker, Ostia, Aorto-Saphenous Vein | KPK | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Acute Coronary Syndrome Event Detector | QBI | Class 3 | Unknown | No | 2025-12-15 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-12-15 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2025-12-15 |
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
Proprietary Names
Mini Ghost
Cyberwand Lithotripter with Sterile Probes
Endoscopic Irrigation/Suction System - Velocity Biopsy Valve
Dual Tip Light
Biopsy Forceps - Enteroscope
Capsule Non-Balloon Button
Electrode
TandemHeart Pump
ProTrack Microcatheter
"EPstar Fixed Electrophysiology Catheter with Lumen EPstar Electrophysiology Cable"
Cyberwand Dual Probe Lithotripter
TandemLung Oxygenator
micro G-Jet
G7 Acetabular System Longevity and Vivacit-E Liners
Pull PEG System
Trilogy Acetabular System Longevity Crosslinked Polyethulene
MED-RX Extension Sets
Zimmer Persona The Personalized Knee System
Dilator Set 14 Fr to 22 Fr
Dislodger, Stone, Flexible - Falcon Grasping Device; Talon Grasping Device
Tubes, Gastrointestinal (And Accessories) - Non-Balloon Replacement PEG
Endoscopic Irrigation/Suction System
Transducer Protectors
Roth Net - Foreign Body Enteroscope
RAM COR-Suture Quickload
Trabecular Metal Acetabular Revision System Cemented Contrained Liner
Z-MED II, 4-18, 20, 22, 23, 25, 26, 28, 30 and 2-6 cm lengths
Stereotaxic Instrument
Vanguard Complete Knee System
NEXEL ELBOW
MED-RX Transfer Set
AMT Capsule Dome Gastrostomy Tube
Cybersonics Cyberwand Hollow Semi-Flexible Ureteral Probe
Dual Mobility Longevity and Vivacit-E Liners
Orthopedic stereotaxic instrument
Mini One Feeding Sets
Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
Z-MED
Atricure Dissector
Isolator Transpolar Pen System
AquaShield System CO2
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MMTA Angio
RD180 Device
Raptor Grasping Device
PowerWire Radiofrequency GuideWire Kit
Pulsavac tip with Shield
MED-RX Pediatric Feeding Tubes and Accessories
iNSitu Total Hip System
PTS-X
Z-MED II
Zimmer Persona Personalized Knee System
Trilogy Longevity Constrained Liner
Polydioxanone Surgical Scaffold
Continuum and Trilogy Integrated Taper Acetabular Systems
Persona Partial Knee
SupraCross Steerable Sheath
Pump, Air, Non-Manual, For Endoscope - AQUASHIELD
Bifurcated Drain Extension
Laparoscope, General & Plastic Surgery - Ponsky Endo-Sock
FS Device
Cyberwand Dual Action Ultrasonic Lithotripsy System
MiniSPC Button
Quick Set-up Kit
Snare, Flexible - Histolock
Endoscopic Irrigation/Suction System - Reveal Distal Attachment Cap
CATHETER, PERCUTANEOUS
Continuum and Triology Integrated Taper (IT)
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula - Bioshield
Quantum Thermal Tubing Sets
VersaCross Transseptal Sheath
Zimmer Continuum Acetabular System
Z-6 Atrioseptostomy Catheter
Impella 2.5 Pump (Pump 250)
Balloon G-Tube
Tyshak NuCLEUS
Symetrex Longterm Hemodialysis Catheter
Tyshak Mini
Identity Shoulder System
Z-MED, 3, 11, 13, 17, 19, 23, 24, 26 mm
Longevity IT Highly CrossLinked Polyethylene Elevated Liners
System, Imaging, Gastrointestinal, Wireless, Capsule - ADVANCE CAPSULE DELIVERY DEVICE
Electrodes
NutraGlide Nasal Feeding Tube
UreTron Sterile Probe
Zimmer Knee Joint Replacement Prostheses MR Labeling
Disposable Reflective Marker Spheres
"EPstar Fixed Electrophysiology Catheter EPstar Electrophysiology Cable "
Catheter, angioplasty, peripheral, transluminal, dual-balloon
RD DEVICE
COEfficient
Nexgen Lps-Flex/Lps-Mobile Bearing Knee
SupraCross RF Wire
Mullins - X
CP Stent
Infusion Pump
Cyberwand Sterile Probe Set
NDI Passive Spheres
Nykanen Radiofrequency Wire
Zimmer Nexel Total Elbow
Snare, Flexible - ISnare System - Hexagonal Snare; ISnare System - Oval Snare
NuCLEUS - X
AMT Balloon Measuring Device
Catheter, intravascular occluding, temporary
"AnchorKnot Tissue Approximation Kit AnchorKnot Knot Pusher (2-0) and AnchorKnot Suture Cutter (2-0) AnchorKnot Suture P
Atrioseptostomy
Coolrail Linear Pen Model
Shock Pulse-SE Lithotripsy System CyberWand II
Pulmonary valve prosthesis percutaneously delivered
Floseal
NRG Transseptal Needle
AnchorKnot Suture
MED-RX Oral/Enteral Syringe
MiniACE
Mullins -X
Balloon Stoma Measuring Device
MED-RX Patient Delivery Set
Endoscopic Irrigation/Suction System - Torrent Irrigation Scope Connector - PENTAX; Torrent Irrigation Tubing
Mini Balloon Button
Persona Partial Knee System
10 mm Silicon Arterial Cannula
Persona Revision Knee System
RD QUICK LOAD SUTURE 0 Polyester
Powered Laser Surgical Instrument
Bipolar System
ATLAS U-Stitch
Optecure Dental
COBRA-OS, Kit Reference Number F01K1
Impact Catheter
Pump, Air, Non-Manual, For Endoscope - AquaShield System - PENTAX; AquaShield System CO2
DYB Introducer Catheter
Tyshak-X
Comprehensive Reverse Shoulder System
Transseptal Cannula EF
Zimmer Biomet Reverse Shoulder Prosthesis
24 Fr Venous Cannula
MMTA Angio Catheter
Mini One Balloon Button
Longevity IT Highly CrossLinked Polyethylene Constrained Liners
Snare, Flexible - Lariat Snare
Traditional G-Jet
PROLONG TIBIAL INSERT
TorFlex Transseptal Guiding Sheath
Endoscopic Cytology Brush - Infinity ERCP Sampling Device
Bypass Vein Canula
RHAPSO Suture Passer
Atrioseptostomy, Braided version
Hoses, Hose Assembly, Single Hose w/CPC Conncectors
Isolator Synergy Clamps
SAF-T-VAC
17 Fr Arterial Cannula
Basic Dilator Kit
Forceps, Biopsy, Electric - Biopsy Forceps - Hot; Biopsy Forceps - Hot - Enteroscope
Resorbable Interference Screw (Screw, Fixation, Bone)
BIB catheter
Continuum
Prolong Highly Crosslinked Polyethylene Cruciate Retaining Articular Surface Components
Wilson Scrotal Pack
Bypass Vein Clamp
MED-RX Extension Set w/ T-Connector
Biopsy Needle - Articulator Injection Needle
Endoscopic Cytology Brush - Cytology Brus
H.A.S. Kit W/O Drain
Guyuron Endoscopic Access Device
EZDilate Balloon Dilator Fixed Wire
Ure Tron Multipore Lithotripter System
ExpanSure Large Access Transseptal Dilator
Single Tip Light
15 Fr Arterial Cannula
NuCLEUS-X PTV Catheter
Guidewire Accessory
Colonoscope And Accessories, Flexible/Rigid - BioGuard Air/Water Suction Valve 2-Piece Kit
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
Longevity IT Highly Crosslinked Polyethyene Liners
Trabecular Metal Revision Shell Liners
Impella Pump 350, DVRS
G- Jet
Anatomical Shoulder TM Combined System
Isolator Multifunctional Linear Pen
Decompression Tube
Transseptal Cannula EF72
Nexgen Prolong All-Poly Patella
Bypass Mrker
VersaCross Steerable Sheath
AngelMed Guardian System
PTS
AMT Introducer (Guidewire Compatible)
Zimmer Persona TM Personailized Knee System
Colonoscope And Accessories, Flexible/Rigid - Oracle EUS Balloon
Snare, Flexible
NesgenComplete Knee Solution
PTV - Pulmonary
NG Tubes
RFP-100A Connector Cable (reusable)
Catheter, Biliary, Surgical - Ponsky Cholangiography System - Taper Tip; Ponsky Guidewire Cholangiography System-Round T
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)