Angiomed U.S., Inc.
Anaheim, CA, US
Angiomed U.S., Inc. appears in FDA device records in Anaheim, CA. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Angiomed U.S., Inc. between 1986 and 1988. The busiest year on record is 1986, with 21. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 21 |
| 1987 | 2 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K874771 | ANGIOMED INTRODUCING SETS | DWB | Substantially Equivalent | |
| K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | DWO | Substantially Equivalent | |
| K864225 | ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT | FAD | Substantially Equivalent | |
| K863386 | VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS | KOB | Substantially Equivalent | |
| K862805 | ANGIOMED VAC-U-CUT BIOPSY NEEDLE | GDM | Substantially Equivalent | |
| K863446 | ANGIOMED HIGH PRESSURE CONNECTORS | GCD | Substantially Equivalent | |
| K854910 | ANGIOFLOW | DQO | Substantially Equivalent | |
| K854912 | ANGIOMED GUIED WIRES | DQX | Substantially Equivalent | |
| K854908 | UROFLEX | FAD | Substantially Equivalent | |
| K855143 | ANGIOMED EXCHANGE DRAINAGE CATHETER SETS | KOD | Substantially Equivalent | |
| K855142 | ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY | FGE | Substantially Equivalent | |
| K855076 | ANGIOMED URETER DIATION SETS | KOD | Substantially Equivalent | |
| K860534 | BILE ENDOPROSTHESIS SET | GBZ | Substantially Equivalent | |
| K855140 | ANGIOMED RENAL DILATION SET | KOD | Substantially Equivalent | |
| K855078 | ANGIO MED DISPOSABLE PRESSURE CONNECTORS | KGZ | Substantially Equivalent | |
| K854652 | ANGIOMED URETERAL STONE DISLODGERS | FFL | Substantially Equivalent | |
| K855141 | ANGIOMED FINE NEEDLES AND NEEDLE SET | GAA | Substantially Equivalent | |
| K855104 | ANGIOMED SKIN FASCIA KNIFE | GES | Substantially Equivalent | |
| K854911 | PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) | GBO | Substantially Equivalent | |
| K854909 | PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS | GBO | Substantially Equivalent | |
| K854907 | PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) | GBO | Substantially Equivalent | |
| K854906 | PERCUTANEOUS NEPHROSTOMY SETS (OTTO) | GBO | Substantially Equivalent | |
| K854905 | PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) | GBO | Substantially Equivalent | |
| K855077 | ANGIOMED HARZMANN DISCS | KOD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KGZAccessories, Catheter
- GESBlade, Scalpel
- GBZCatheter, Cholangiography
- DQOCatheter, Intravascular, Diagnostic
- GBOCatheter, Nephrostomy, General & Plastic Surgery
- KOBCatheter, Suprapubic (And Accessories)
- KODCatheter, Urological
- GCDConnector, Catheter
- FFLDislodger, Stone, Basket, Ureteral, Metal
- GAANeedle, Aspiration And Injection, Disposable
- GDMNeedle, Aspiration And Injection, Reusable
- DWONeedle, Biopsy, Cardiovascular
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
- FADStent, Ureteral
- FGEStents, Drains And Dilators For The Biliary Ducts
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain