Product code HRM— General, Plastic Surgery

FDA has cleared 14 devices under product code HRM between 1979 and 1993, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19932 clearances
• 19922 clearances
• 19892 clearances
• 19855 clearances
• 19841 clearance
• 19821 clearance
• 19791 clearance

• Keeler Instruments, Inc.4 clearances
• Xtal Corp.1 clearance
• Treace Medical, Inc.1 clearance
• Seltrex, Corp.1 clearance
• Prescott'S, Inc.1 clearance
• Mentor O & O, Inc.1 clearance
• Marco Ophthalmic, Inc.1 clearance
• Lumenis, Inc.1 clearance
• Hill-Med, Inc.1 clearance
• Carl Zeiss, Inc.1 clearance

• K932720 — HM-0970Hill-Med, Inc.·1993-09-07
• K930439 — MARCO SURGISCOPE OPERATION MICROSCOPESMarco Ophthalmic, Inc.·1993-07-22
• K920641 — ALCON OPERATING MICROSCOPESAlcon Laboratories·1992-10-09
• K914956 — KEELER KONAN SPECULAR MICROSCOPE SP5500Keeler Instruments, Inc.·1992-02-03
• K891584 — S 22 INSTRUMENT STANDCarl Zeiss, Inc.·1989-06-08
• K891001 — MICROSCOPE KNOB COVER, STERILE, DISPOSABLEPrescott'S, Inc.·1989-04-11
• K854440 — MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50Keeler Instruments, Inc.·1985-12-16
• K853855 — XTAL X-150 OPERATING MICROSCOPEXtal Corp.·1985-10-15
• K852586 — CROMIC SURGICAL MICROSCOPE MODEL MC-1Seltrex, Corp.·1985-07-30
• K852150 — CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500Keeler Instruments, Inc.·1985-06-03
• K850270 — CORNEAL LIGHT SHIELDMentor O & O, Inc.·1985-05-31
• K844323 — KONAN CLINIC MICROSCOPE CLM-100-150Keeler Instruments, Inc.·1984-11-21
• K822563 — OPHTHALMIC MICROSCOPETreace Medical, Inc.·1982-09-14
• K792083 — HAAG-STREIT SLIT LAMP 900Lumenis, Inc.·1979-11-16