Harmac Medical Products
Buffalo, NY, US
HARMAC MEDICAL PRODUCTS appears in FDA device records in Buffalo, NY. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Harmac Medical Products between 1995 and 2002. The busiest year on record is 1997, with 6. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1997 | 6 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K021916 | HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 | FPA | Substantially Equivalent | |
| K963335 | HARMAC BALLOON WEDGE PRESSURE CATHETER | DQO | Substantially Equivalent | |
| K962829 | HARMAC BALLOON ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K962833 | HARMAC TEMPORARY PACING CATHETER WITH BALLOON | LDF | Substantially Equivalent | |
| K963336 | HARMAC THERMODILUTION CATHETER | DYG | Substantially Equivalent | |
| K963073 | HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET | LDF | Substantially Equivalent | |
| K963074 | HARMAC QUADPOLAR MAPPING PACING CATHETER | DRF | Substantially Equivalent | |
| K950895 | HARMAC EXTENSION INFUSION SET | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003630504 | 3002468842 | HARMAC MEDICAL PRODUCTS | I.D.A. BUSINESS PARK, CASTLEREA Roscommon -- IE | 2026 | |
| 1317547 | 1317547 | HARMAC MEDICAL PRODUCTS, INC. | 2201 BAILEY AVE., BUFFALO, NY 14211 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PJQAgent, Occluding, Vascular, Permanent
- FDPApparatus, Pneumoperitoneum, Automatic
- GEACannula, Surgical, General & Plastic Surgery
- JOLCatheter And Tip, Suction
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- LDFElectrode, Pacemaker, Temporary
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- QKLLipoaspirate Washing System For Aesthetic Body Contouring
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- QNBPlasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein
- FPASet, Administration, Intravascular
- FGEStents, Drains And Dilators For The Biliary Ducts
- LNRSystem, Photopheresis, Extracorporeal
- HQCUnit, Phacofragmentation
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain