Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
147865–147888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1985
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
K853049 · CIX
Simmler, Inc.
Chemistry · 14d
Cleared Aug 02, 1985
CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ
K853050 · CIC
Simmler, Inc.
Chemistry · 14d
Cleared Aug 02, 1985
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
K853084 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 10d
Cleared Aug 02, 1985
UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN
K853102 · CDQ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 10d
Cleared Aug 01, 1985
PERMALID PAK
K842781
CooperVision, Inc.
Ophthalmic · 381d
Cleared Aug 01, 1985
PERMALID LINER PAK
K842814
CooperVision, Inc.
Ophthalmic · 379d
Cleared Aug 01, 1985
EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT
K844596
Xanmed Corp.
General & Plastic Surgery · 248d
Cleared Aug 01, 1985
ACCU-CHEK II
K851456 · CGA
Boehringer Mannheim Corp.
Chemistry · 112d
Cleared Aug 01, 1985
THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY
K851495
Thoratec Laboratories Corp.
General & Plastic Surgery · 108d
Cleared Aug 01, 1985
MDS 83 OPHTHALMIC DYE LASER SYSTEM
K852234 · HQF
Meditec, Inc.
Ophthalmic · 71d
Cleared Aug 01, 1985
INFUSION CANNULAM
K852758 · HMX
Precision Medical Instruments, Inc.
Ophthalmic · 34d
Cleared Aug 01, 1985
CARIOLINE(ELECTROCARDIOGRAPH)
K852770 · DPS
Remco Italia S.P.A.
Cardiovascular · 34d
Cleared Aug 01, 1985
ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST
K852840 · LJM
Modern Diagnostics, Inc.
Immunology · 27d
Cleared Aug 01, 1985
MYCOPLASMA SPP SEROLOGICAL REAGENTS
K852933 · GSB
Microbix Biosystems, Inc.
Microbiology · 23d
Cleared Aug 01, 1985
RF CARD TEST
K853054 · DHR
Preco, Inc.
Immunology · 13d
Cleared Aug 01, 1985
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073 · GTZ
Marion Laboratories, Inc.
Microbiology · 9d
Cleared Jul 31, 1985
ULTRATHIN/SP LENS
K843957 · HRG
Optical Systems Intl., Inc.
Ophthalmic · 294d
Cleared Jul 31, 1985
TUBULITEC PRIMER
K851052 · LBH
Dental Therapeutics AB
Dental · 139d
Cleared Jul 31, 1985
CUPRIDENT
K851073 · EJR
Bio Systems, Inc.
Dental · 135d
Cleared Jul 31, 1985
TROPHY COMPACT - DENTAL UNIT
K851136 · EIA
Trophy Radiologie
Dental · 132d
Cleared Jul 31, 1985
ANNE MARIE PERRIS SUNGLASSES AND FRAMES
K851698 · HQY
Perlinea Co.
Ophthalmic · 98d
Cleared Jul 31, 1985
OMRON DIGITAL BP MONITOR HEM-400C
K851707 · DXN
Omron Tateisi Electronics Co.
Cardiovascular · 97d
Cleared Jul 31, 1985
RESTORE*
K851929 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 90d
Cleared Jul 31, 1985
COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM
K852102 · CCM
Warren E. Collins, Inc.
Anesthesiology · 77d