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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
154633–154656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1984
NABI CRP-Q.S. TEST
K834584 · DCN
Intl. Diagnostic, Inc.
Immunology · 60d
Cleared Feb 27, 1984
WILCOR-XR RP-OG MEDICAL FILM
K834612 · IWZ
Cea America Corp.
Radiology · 69d
Cleared Feb 27, 1984
INDIRECT FLUORESCENT ANTIBODY MYCO
K840012 · GRZ
Zeus Technologies
Microbiology · 54d
Cleared Feb 27, 1984
VACUUM STRETCHER IMMOBILIZER
K840034 · FPP
Medicon, Inc.
General Hospital · 53d
Cleared Feb 27, 1984
TOTAL HIP FEMORAL COMPONENT
K840150 · JDI
Advanced Biosearch Assn.
Orthopedic · 45d
Cleared Feb 27, 1984
EPIDURAL CATHETER
K840202 · BSO
Aries Medical, Inc.
Anesthesiology · 39d
Cleared Feb 27, 1984
POIRIER VARIABLE WHEELCHAIR
K840234 · IQC
Poirier S.A.
Physical Medicine · 38d
Cleared Feb 27, 1984
PATIENT MONITOR 78534B
K840251 · DRT
Hewlett-Packard Co.
Cardiovascular · 54d
Cleared Feb 27, 1984
RIM GRAM REACTION SWAB
K840252 · JTO
Austin Biological Laboratories
Microbiology · 35d
Cleared Feb 27, 1984
LIFECARE 4/HOMECARE - 4H PUMP
K840263 · FRN
Abbott Laboratories
General Hospital · 35d
Cleared Feb 27, 1984
VIDEO PRINT
K840385 · LMC
Advanced Instruments, Inc.
Radiology · 28d
Cleared Feb 27, 1984
NOVOX OXYGEN ANALYZER 400
K840392 · CCL
Novametrix Medical Systems, Inc.
Anesthesiology · 28d
Cleared Feb 27, 1984
DTM AGAR
K840519 · JSJ
Scientific Device Laboratory, Inc.
Microbiology · 21d
Cleared Feb 27, 1984
MYCOLOGICAL SELECTIVE MEDIUM
K840520 · JSJ
Scientific Device Laboratory, Inc.
Microbiology · 21d
Cleared Feb 27, 1984
BLOOD AGAR W/AMPICILLIN
K840554 · JSJ
Remel Co.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST OXIDASE REAGENT
K840575 · JTO
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST DMACA INDOLE REAGENT
K840576 · JTO
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST KOVACS' INDOLE REAGENT
K840577 · JTO
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST VOGES-PROSKAUER REAGENT A
K840578 · JTO
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST NITRATE REAGENT A
K840579 · JTO
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST NITRATE REAGENT B
K840580 · JTO
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST NITRATE REAGENT C
K840581 · JTO
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST FERRIC CHLORIDE REAGENT
K840582 · JTO
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST VOGES-PROSKAUER REAGENT B
K840583 · JTO
Difco Laboratories, Inc.
Microbiology · 19d