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
141577–141600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1987
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
K864619 · KRL
Shiley, Inc.
Cardiovascular · 71d
Cleared Feb 03, 1987
GC-LECT(TM)
K864803 · JTY
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Feb 03, 1987
TUPPER TROLLEY
K870102 · HST
Orthopedic Systems, Inc.
Neurology · 25d
Cleared Feb 03, 1987
FEMUR WRENCH
K870126 · GEG
Orthopedic Systems, Inc.
General & Plastic Surgery · 22d
Cleared Feb 03, 1987
URESIL T-SYSTEM BONE SCREWS
K870141 · HWC
Uresil Corp.
Orthopedic · 21d
Cleared Feb 02, 1987
THE GOLDEN QUAD TEST (HSV)
K861120 · GQO
Microbiological Research Corp.
Microbiology · 314d
Cleared Feb 02, 1987
THE GOLDEN QUAD TEST (EBV)
K861121 · GNP
Microbiological Research Corp.
Microbiology · 314d
Cleared Feb 02, 1987
THE GOLDEN QUAD TEST (TOXO)
K861122 · LJK
Microbiological Research Corp.
Microbiology · 314d
Cleared Feb 02, 1987
THE GOLDEN QUAD TEST (CMV)
K861123 · GQI
Microbiological Research Corp.
Microbiology · 314d
Cleared Feb 02, 1987
OSTEOPAK BMD (BONE MINERAL DENSITOMETER)
K861515 · KGI
Siemens Gammasonics, Inc.
Radiology · 285d
Cleared Feb 02, 1987
EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND
K862859 · DXK
Biosound, Inc.
Cardiovascular · 188d
Cleared Feb 02, 1987
MICRODILUTION MIC PANELS
K863776 · JWY
American Micro Scan
Microbiology · 130d
Cleared Feb 02, 1987
CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY
K864315 · LFX
Cytotech, Inc.
Microbiology · 91d
Cleared Feb 02, 1987
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA
K864347 · GNP
Granbio, Inc.
Microbiology · 90d
Cleared Feb 02, 1987
LYMPHOCYTE MAINTENANCE MEDIUM
K864396 · KIT
Bioclinical Laboratory Services, Inc.
Pathology · 88d
Cleared Feb 02, 1987
EXTRA STRONG CONDOM
K864400 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 88d
Cleared Feb 02, 1987
CMV MICROASSAY
K864420 · GQI
Diamedix Corp.
Microbiology · 84d
Cleared Feb 02, 1987
EGG-TOP TORP AND EGG-TOP PORP
K864443 · ETA
Richards Medical Co., Inc.
Ear, Nose, Throat · 82d
Cleared Feb 02, 1987
DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
K864449 · DPO
Canadian Bioclinical, Ltd.
Chemistry · 82d
Cleared Feb 02, 1987
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
K864452 · CDP
Lkb Instruments, Inc.
Chemistry · 82d
Cleared Feb 02, 1987
REVISED RESISTANT 5 MIC PANEL
K864493 · JWY
Pasco Laboratories, Inc.
Microbiology · 80d
Cleared Feb 02, 1987
SPERM SELECT(TM)
K864524 · MQL
Pharmacia, Inc.
Pathology · 77d
Cleared Feb 02, 1987
ALFERR TIBC TUBE
K864548 · JQE
Benchmark Reagents
Chemistry · 75d
Cleared Feb 02, 1987
EBV VCA IGM ANTIBODY ASSAY KIT
K864604 · LJN
Granbio, Inc.
Microbiology · 70d