Product code KXZ— Obstetrics/Gynecology

FDA has cleared 7 devices under product code KXZ between 1977 and 1985, filed by 6 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

• 19851 clearance
• 19842 clearances
• 19821 clearance
• 19791 clearance
• 19772 clearances

• E-Z-Em, Inc.2 clearances
• Qmax Medical, Inc.1 clearance
• Medtech Products, Inc.1 clearance
• Cutter Laboratories, Inc.1 clearance
• Bcd Products, Inc.1 clearance
• American Thermal Instruments, Inc.1 clearance

• K851034 — NOVATHERMMedtech Products, Inc.·1985-09-27
• K843124 — Q-SCAN THERMOGRAPHY SYSTEMQmax Medical, Inc.·1984-11-29
• K832731 — BREAST & BODY HEALTH SYSTEM 2000American Thermal Instruments, Inc.·1984-01-30
• K813547 — THERMASCANBcd Products, Inc.·1982-03-12
• K781916 — FLEXT-THERME-Z-Em, Inc.·1979-02-02
• K770986 — FLEXI-THERM FILME-Z-Em, Inc.·1977-09-12
• K770678 — ELC-THERMO-SYSTEMCutter Laboratories, Inc.·1977-05-25