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

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175,820 results
148009–148032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 1985
THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL
K851641 · MSJ
Ortho Diagnostic Systems, Inc.
Hematology · 95d
Cleared Jul 23, 1985
HGM ENDOCOAGULATOR MODEL 8
K851651
Hgm, Inc.
General & Plastic Surgery · 92d
Cleared Jul 23, 1985
QUICK-COUNT HEMATOLOGY CONTROLS
K851663 · JPK
Seragen Diagnostics, Inc.
Hematology · 91d
Cleared Jul 23, 1985
MONITOR IV PLUS
K851669 · JOZ
Helena Laboratories
Hematology · 91d
Cleared Jul 23, 1985
OPSITE WOUND DRESSING
K852211 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 63d
Cleared Jul 23, 1985
SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP
K852539 · LFL
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 39d
Cleared Jul 23, 1985
MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
K852544 · FMF
Sherwood Medical Co.
General Hospital · 39d
Cleared Jul 23, 1985
MONOJECT STERILE 60CC SYRINGES
K852580 · FMF
Sherwood Medical Co.
General Hospital · 35d
Cleared Jul 23, 1985
MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES
K852588 · FMF
Sherwood Medical Co.
General Hospital · 35d
Cleared Jul 23, 1985
MONJECT STERILE 20CC SYRINGES
K852607 · FMF
Sherwood Medical Co.
General Hospital · 34d
Cleared Jul 23, 1985
MONOJECT STERILE 35CC SYRINGES
K852640 · FMF
Sherwood Medical Co.
General Hospital · 33d
Cleared Jul 23, 1985
AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE
K852752 · CJE
American Research Products Co.
Chemistry · 25d
Cleared Jul 23, 1985
TECHNICON H*1 SYSTEM
K852787
Technicon Instruments Corp.
Hematology · 22d
Cleared Jul 23, 1985
CHOLESTEROL METHOD
K852863 · CHH
Catachem, Inc.
Chemistry · 15d
Cleared Jul 23, 1985
BARRIER SURGICAL GOWN
K852870 · FYA
Surgikos, Inc.
General Hospital · 15d
Cleared Jul 23, 1985
IDS RAPID SS/U SYSTEM
K852871 · JSS
Innovative Diagnostic Systems, Inc.
Microbiology · 15d
Cleared Jul 23, 1985
MUG DISK
K852886 · JTO
Remel Co.
Microbiology · 14d
Cleared Jul 23, 1985
GENERAL DIAGNOSTICS RAPID E. COLI TEST
K852889 · JTO
Warner-Lambert Co.
Microbiology · 14d
Cleared Jul 23, 1985
NEISSERIA - KWIK PLUS
K852998 · JSX
Micro-Bio-Logics
Microbiology · 8d
Cleared Jul 22, 1985
MACULAR FUNCTION ANALYZER
K843227 · HOQ
Danek Medical, Inc.
Ophthalmic · 340d
Cleared Jul 22, 1985
ELECTRONYSTAGMOGRAPH (ENG RECORDER)
K850180 · GWN
Bio-Logic Systems Corp.
Neurology · 186d
Cleared Jul 22, 1985
V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES
K851082 · ENW
American V. Mueller
Ear, Nose, Throat · 126d
Cleared Jul 22, 1985
COMBINED MVS SYSTEMS
K851610 · HQE
Medical Instrument Development...
Ophthalmic · 98d
Cleared Jul 22, 1985
CEDIA TOTAL T4 ASSAY
K852164 · KLI
Microgenics Corp.
Chemistry · 63d