Product code HDD— Obstetrics/Gynecology

FDA has cleared 7 devices under product code HDD between 1977 and 1995, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19951 clearance
• 19921 clearance
• 19882 clearances
• 19811 clearance
• 19772 clearances

• Adel Medical , Ltd.2 clearances
• Stryker Corp.1 clearance
• I E Industries1 clearance
• Hill-Rom, Inc.1 clearance
• Alton Dean Medical, Inc.1 clearance
• Affiliated Hospital Products, Inc.1 clearance

• K950889 — ADEL 5000Stryker Corp.·1995-10-16
• K914309 — THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIESHill-Rom, Inc.·1992-04-20
• K875123 — ORCEPADAlton Dean Medical, Inc.·1988-06-21
• K874610 — ADEL MODEL 2100 BIRTHING BEDAdel Medical , Ltd.·1988-01-21
• K810886 — ADEL MEDICAL BIRTHING BED, #LD-500Adel Medical , Ltd.·1981-04-23
• K771942 — TILT 10, CATALOG #S-2600Affiliated Hospital Products, Inc.·1977-10-27
• K770438 — CART, PROCEDURESI E Industries·1977-07-01