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
146689–146712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1985
CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
K852929 · GQI
Microbix Biosystems, Inc.
Microbiology · 126d
Cleared Nov 12, 1985
VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
K852930 · GQX
Microbix Biosystems, Inc.
Microbiology · 126d
Cleared Nov 12, 1985
HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
K852931 · GQO
Microbix Biosystems, Inc.
Microbiology · 126d
Cleared Nov 12, 1985
MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
K852932 · GRF
Microbix Biosystems, Inc.
Immunology · 126d
Cleared Nov 12, 1985
NITROGLYCERIN INFUSION SET
K853019 · FPA
Lyphomed, Inc.
General Hospital · 118d
Cleared Nov 12, 1985
TECHNA VISION AUTO-PERIMETER
K853290 · HPT
Techna Vision
Ophthalmic · 99d
Cleared Nov 12, 1985
21 HEMATOLOGY REAGENTS
K853304 · GKZ
In Vitro Diagnostics, Inc.
Hematology · 99d
Cleared Nov 12, 1985
VIROGEN ROTATEST SLIDE TEST
K853399 · LIQ
Armkel, LLC
Microbiology · 92d
Cleared Nov 12, 1985
MCGAW/DROP WATCH FLOW MONITOR
K853549 · FLN
American Mcgaw
General Hospital · 78d
Cleared Nov 12, 1985
CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP
K853584 · FRN
Deltec Systems, Inc.
General Hospital · 78d
Cleared Nov 12, 1985
ACE-KYLE DYE INJECTION NEEDLE P/N 14082
K853604 · FMI
Today'S Machining & Design, Inc.
General Hospital · 76d
Cleared Nov 12, 1985
FRESENIUS DISPOSABLE BLOOD LINES
K853851 · FJK
Seratronics, Inc.
Gastroenterology & Urology · 57d
Cleared Nov 12, 1985
OPHTHALMIC LASER PHOTOCOAGULATOR
K853890 · HQF
Mira, Inc.
Ophthalmic · 54d
Cleared Nov 12, 1985
THROMBOPLASTIN-R REAGENT
K853986 · JPA
American Dade
Hematology · 46d
Cleared Nov 12, 1985
MICRO THERM MT-500 & MT-600
K854035 · FLL
Medequi, Division of King Yip Co., Inc.
General Hospital · 42d
Cleared Nov 12, 1985
DOUBLE ANTIBODY C-PEPTIDE RIA KIT
K854066 · JKD
Diagnostic Products Corp.
Chemistry · 39d
Cleared Nov 12, 1985
LEUCO PREP
K854093 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 36d
Cleared Nov 12, 1985
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
K854108 · LHL
Medical Diagnostic Technologies, Inc.
Microbiology · 35d
Cleared Nov 12, 1985
KODAKEKTACHEM DTR MODULE
K854138 · JJE
Eastman Kodak Company
Chemistry · 33d
Cleared Nov 12, 1985
THE ULTRA-MATE LENS
K854218 · HQG
Optical Systems Intl., Inc.
Ophthalmic · 26d
Cleared Nov 12, 1985
MEBIASIS AGAR GEL DIFFUSION KIT
K854230 · KHW
Lmd Laboratories
Microbiology · 22d
Cleared Nov 12, 1985
THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE
K854244 · HLI
Keeler Instruments, Inc.
Ophthalmic · 22d
Cleared Nov 12, 1985
SPAN / AID SYRINGE
K854255 · FMF
Span-America Medical Systems, Inc.
General Hospital · 21d
Cleared Nov 12, 1985
SUNGLASSES/OPTICAL FRAMES
K854264 · HQY
Wha Chun Industries, Co., Ltd.
Ophthalmic · 20d