Panels › Obstetrics/Gynecology › Product code HDY · Class 2
Dilator, Cervical, Hygroscopic-Laminaria
Regulation 884.4260
0510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HDY
| Company | 510(k)s | Recalls |
|---|---|---|
| A & A Medical, Inc. | 1 | 0 |
| Atad Developments , Ltd. | 1 | 0 |
| Berkeley Medevices | 1 | 0 |
| British Marketing Ent., Ltd. | 1 | 0 |
| Busse Hospital Disposables, Inc. | 1 | 0 |
| Cti Corp., Ltd. | 1 | 0 |
| Harold W. Berger Co. | 1 | 0 |
| Medgyn Products, Inc. | 1 | 0 |
| Medi-Spec | 1 | 0 |
| Quality Medical Solusions, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 18, 2005 | K040625 | ATAD ARD CATHETER Atad Developments , Ltd., IL | HDY |
| Jun 25, 2002 | K021012 | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM Quality Medical Solusions, LLC | HDY |
| Jul 9, 2001 | K011512 | MMODIFICATION TO LAMINARIA A & A Medical, Inc. | HDY |
| May 22, 1996 | K955072 | LAMINARIA Cti Corp., Ltd. | HDY |
| Jun 14, 1989 | K892220 | LAMINARIA TENT Berkeley Medevices | HDY |
| Aug 10, 1988 | K881295 | LAMINARIA CUREX Harold W. Berger Co. | HDY |
| May 23, 1988 | K881312 | LAMINARIA Busse Hospital Disposables, Inc. | HDY |
| May 6, 1988 | K880196 | LAMINARIA Medgyn Products, Inc. | HDY |
| May 1, 1985 | K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR Sun Medical, Inc. | HDY |
| Feb 4, 1984 | K833068 | LAMINARIA JAPONICA CERVICAL DILATOR Medi-Spec | HDY |
| Jan 3, 1979 | K782067 | DILATOR, MIZUTANI LAMINARIA TENT British Marketing Ent., Ltd. | HDY |
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