American Medical Products LLC
Eatontown, NJ, US
AMERICAN MEDICAL PRODUCTS LLC appears in FDA device records in Eatontown, NJ. FDA records list 30 510(k) clearances between and , no PMA records and one registered establishment. 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 30 510(k) clearances for American Medical Products LLC between 1978 and 1992. The busiest year on record is 1982, with 9. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 4 |
| 1981 | 8 |
| 1982 | 9 |
| 1983 | 2 |
| 1986 | 2 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K922290 | SINGLE-STEP PREGNANCY, HCG TEST | JHI | Substantially Equivalent | |
| K862221 | E-Z CLEAN | GEI | Substantially Equivalent | |
| K861251 | AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N | KNX | Substantially Equivalent | |
| K830881 | AMPERCIDE DISINFECTANT ACCESSORY TO - | FKX | Substantially Equivalent | |
| K823827 | AMP 80/2 OUTFLOW MONITOR MODIFICATION | FKX | Substantially Equivalent | |
| K822551 | AMP CAPD UNISPIKE AMINISTRATION SET | FKK | Substantially Equivalent | |
| K822550 | SAFE LOCK TITANIUM ADAPTER SET | FKX | Substantially Equivalent | |
| K822549 | CCPD CYCLER SET W/5 PRONGED SAFE LOCK | FKX | Substantially Equivalent | |
| K822548 | SAFE LOCK CATHETER S-3 | FKX | Substantially Equivalent | |
| K822546 | SAFE LOCK SEALING CAPS | FKX | Substantially Equivalent | |
| K822545 | CCPD CYCLER SET W/5 PRONGED CONNECTOR | FKX | Substantially Equivalent | |
| K822544 | SAFE LOCK SEALING CAP L | FKX | Substantially Equivalent | |
| K822543 | CAPD SAFE LOCK TRANSFER SET | FKX | Substantially Equivalent | |
| K822547 | CAPD BELT | FKX | Substantially Equivalent | |
| K813069 | PERITONEAL DIALYSIS CYCLER SET | KDJ | Substantially Equivalent | |
| K811986 | THE AMP 80/2 PEDIATRIC CYCLER SYSTEM | FKX | Substantially Equivalent | |
| K811917 | I.V. ADMIN. SETS FOR THE AMP MARK IV PMP | FRN | Substantially Equivalent | |
| K811918 | AMP MARK IV INFUSION PUMP | FRN | Substantially Equivalent | |
| K810840 | AMP PERITONEAL DIALYSIS PREP KIT | KDJ | Substantially Equivalent | |
| K810671 | CCPD 3 LITER DRAINAGE SET | KDJ | Substantially Equivalent | |
| K810670 | CCPD CYCLER SET | KDJ | Substantially Equivalent | |
| K810236 | MIROMED PERITONEAL DIALYSIS CATHETER | FJS | Substantially Equivalent | |
| K802600 | AMP PORTABLE PATIENT PRESSURE MONITOR | DSK | Substantially Equivalent | |
| K801220 | PERITONEAL DIALYSIS CYCLER SET W/PUMP | KDJ | Substantially Equivalent | |
| K800496 | CYCLER W/5 OR 10 HR. FILL/DWELL TIMER | KPF | Substantially Equivalent | |
| K792646 | AMP DIRECT VASCULAR MONITORING SYSTEM | KRH | Substantially Equivalent | |
| K791722 | DISPOSABLE PERITONEAL DIALYSIS EXTENSION | KDJ | Substantially Equivalent | |
| K791584 | CYLER/HEATER FOR PERITONEAL DIALYSIS | KPF | Substantially Equivalent | |
| K790091 | AMP AUTOMATIC CYCLER STAND | KPF | Substantially Equivalent | |
| K780957 | SET, ADMINISTRATION, MANUAL, DIALYSIS | KDJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008364966 | 3008364966 | AMERICAN MEDICAL PRODUCTS LLC | 151 Industrial Way East, Eatontown, NJ 07724 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FJSCatheter, Peritoneal, Long-Term Indwelling
- FKKClamp, Line
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- DSKComputer, Blood-Pressure
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- IQEOrthosis, Lumbar
- IPYOrthosis, Lumbo-Sacral
- IPTOrthosis, Thoracic
- IMEPack, Hot Or Cold, Reusable
- FRNPump, Infusion
- KRHRing, Annuloplasty
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- ILISling, Arm
- IOYSupport, Arm
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal
- FKXSystem, Peritoneal, Automatic Delivery
- JHIVisual, Pregnancy Hcg, Prescription Use
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