LYNX Medical Pennsylvania

FDA Device Registration & Listing · ERIE, PA, US · Registration 2528981

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
2528981
FEI Number
2528981
Entity Name
LYNX Medical Pennsylvania
City/State/Country
ERIE, PA, US
Establishment Address
2205 E 33rd St, ERIE, PA 16510, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
LYNX Medical Pennsylvania (Owner Number: 10094665)
Owner / Operator Contact Address
2205 East 33rd St, Erie, PA 16510, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Mini Ghost "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 Stereotaxic Instrument AquaShield System CO2 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer MMTA Angio Stereotaxic Instrument RD180 Device Raptor Grasping Device Electrode 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 iNSitu Total Hip System 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 iNSitu Total Hip System 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 Z-MED II 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 Nykanen Radiofrequency Wire MiniACE Mullins -X Balloon Stoma Measuring Device MED-RX Patient Delivery Set Endoscopic Irrigation/Suction System - Torrent Irrigation Scope Connector - PENTAX; Torrent Irrigation Tubing Atrioseptostomy Mini Balloon Button Persona Partial Knee System 10 mm Silicon Arterial Cannula Catheter, angioplasty, peripheral, transluminal, dual-balloon Persona Revision Knee System RD QUICK LOAD SUTURE 0 Polyester Powered Laser Surgical Instrument iNSitu Total Hip System 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 Zimmer Persona Personalized Knee System CATHETER, PERCUTANEOUS Tyshak-X Comprehensive Reverse Shoulder System Transseptal Cannula EF Stereotaxic Instrument Zimmer Biomet Reverse Shoulder Prosthesis 24 Fr Venous Cannula PTS-X MMTA Angio Catheter Zimmer Persona The Personalized Knee System Pulmonary valve prosthesis percutaneously delivered 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 Tyshak Mini Isolator Synergy Clamps SAF-T-VAC 17 Fr Arterial Cannula Basic Dilator Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2025-12-15
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2025-12-15
FTD Lamp, Surgical General, Plastic Surgery Class 2 878.4580 2025-12-15
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
GZL Electrode, Depth Neurology Class 2 882.1330 2025-12-15
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2025-12-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2025-12-15
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2025-12-15
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-15
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-12-15
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-12-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2025-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-12-15
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2025-12-15
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2025-12-15
FGO Dislodger, Stone, Flexible Gastroenterology, Urology Class 2 876.4680 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2025-12-15
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2025-12-15
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2025-12-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-12-15
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2025-12-15
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2025-12-15
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2025-12-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-12-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-15
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2025-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-12-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2025-12-15
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2025-12-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2025-12-15
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-12-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2025-12-15
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-12-15
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2025-12-15
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2025-12-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-12-15
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2025-12-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-15
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2025-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-12-15
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-12-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-15
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2025-12-15
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2025-12-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-12-15
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2025-12-15
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2025-12-15
GZL Electrode, Depth Neurology Class 2 882.1330 2025-12-15
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2025-12-15
FQH Lavage, Jet General Hospital Class 2 880.5475 2025-12-15
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2025-12-15
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2025-12-15
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2025-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-12-15
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2025-12-15
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2025-12-15
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2025-12-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2025-12-15
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2026-04-30
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-12-15
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2025-12-15
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2025-12-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-12-15
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2025-12-15
HEW Culdoscope (And Accessories) Obstetrics/Gynecology Class 2 884.1640 2025-12-15
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2026-04-30
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2026-04-30
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2025-12-15
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2025-12-15
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2025-12-15
BSB Warmer, Blood, Non-Electromagnetic Radiation Hematology Class 2 864.9205 2025-12-15
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2025-12-15
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-12-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-12-15
OZD Temporary Non-Roller Type Left Heart Support Blood Pump Unknown Class 3 N/A 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-12-15
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-12-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2025-12-15
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2025-12-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2025-12-15
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-12-15
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2025-12-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule Gastroenterology, Urology Class 2 876.1300 2025-12-15
GZL Electrode, Depth Neurology Class 2 882.1330 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2025-12-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2025-12-15
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2025-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-12-15
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2025-12-15
OZT Balloon Aortic Valvuloplasty Cardiovascular Class 2 870.1255 2025-12-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-15
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2025-12-15
NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon Cardiovascular Class 2 870.1250 2025-12-15
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-12-15
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2025-12-15
OMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter Cardiovascular Class 2 870.1250 2025-12-15
NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown Class 3 N/A 2025-12-15
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
PNF Aortic Stent Unknown Class 3 N/A 2025-12-15
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2025-12-15
FRN Pump, Infusion General Hospital Class 2 880.5725 2025-12-15
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2025-12-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-15
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-12-15
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2025-12-15
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2026-04-30
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2025-12-15
HRX Arthroscope Orthopedic Class 2 888.1100 2025-12-15
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-12-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-12-15
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-12-15
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2025-12-15
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2025-12-15
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2025-12-15
LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery Class 3 878.4490 2025-12-15
PMX Absorbable Collagen Hemostatic Agent With Thrombin General, Plastic Surgery Class 3 878.4490 2025-12-15
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-12-15
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
EXD Irrigator, Ostomy Gastroenterology, Urology Class 2 876.5895 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-12-15
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2025-12-15
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2025-12-15
OMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter Cardiovascular Class 2 870.1250 2025-12-15
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-12-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2025-12-15
DSQ Ventricular (Assist) Bypass Unknown Class 3 N/A 2025-12-15
NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon Cardiovascular Class 2 870.1250 2025-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-12-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2025-12-15
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2025-12-15
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2025-12-15
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2025-12-15
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2025-12-15
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2025-12-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-15
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2025-12-15
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-12-15
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2025-12-15
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2025-12-15
NUN Bone Grafting Material, Human Source Dental Class 2 872.3930 2025-12-15
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2025-12-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-12-15
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2025-12-15
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-12-15
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2025-12-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2025-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2025-12-15
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2025-12-15
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-12-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2025-12-15
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2025-12-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-15
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2026-04-30
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2026-04-30
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-04-30
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-04-30
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2026-04-30
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2025-12-15
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2025-12-15
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-12-15
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2025-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-12-15
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2025-12-15
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-12-15
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2025-12-15
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2025-12-15
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2025-12-15
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2026-04-30
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2026-04-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2026-04-30
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-12-15
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2025-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-15
OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2025-12-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-12-15
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2025-12-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-15

Official Correspondent

Heather Parker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LYNX Medical Pennsylvania
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
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19
K082339 Endocross, Ltd. ENABLER-P SUPPORT CATHETER 2008-11-20
K210009 CenterPoint Systems, LLC Guiding Catheter 2021-11-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2528981. Last updated year: 2026. Please use registration number 2528981 when referencing this establishment in official correspondence.
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