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
141001–141024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1987
ABUSCREEN (R) EIA BARBITURATE
K870378 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Mar 16, 1987
MOBILIMB HAND EXERCISER
K870402 · BXB
Biodynamic Technologies, Inc.
Physical Medicine · 42d
Cleared Mar 16, 1987
GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA
K870507 · DWF
Research Medical, Inc.
Cardiovascular · 39d
Cleared Mar 16, 1987
CHART-TYPE MICRO HEMATOCRIT TUBE READER
K870511 · JPI
Norfolk Scientific, Inc.
Hematology · 39d
Cleared Mar 16, 1987
ACCELOGRAPH
K870619 · BXN
Biometer Intl. A/S
Anesthesiology · 32d
Cleared Mar 16, 1987
CHALLENGER DOSIMETER
K870755 · CCQ
Salter Labs
Anesthesiology · 18d
Cleared Mar 16, 1987
BODYSCAN
K870818 · IYX
Siemens Gammasonics, Inc.
Radiology · 13d
Cleared Mar 13, 1987
SHBG IRMA KIT
K861679 · CDZ
Farmos Group , Ltd.
Chemistry · 316d
Cleared Mar 13, 1987
EPISON, ALERTING SYSTEM FOR EPILEPTICS
K862766 · LEL
Zygo Industries, Inc.
Neurology · 234d
Cleared Mar 13, 1987
SYVA ETS SYSTEM
K863245 · JJF
Syva Co.
Chemistry · 203d
Cleared Mar 13, 1987
UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE
K864174 · JHI
United Biotech, Inc.
Chemistry · 140d
Cleared Mar 13, 1987
CO2 REAGENT SET
K864313 · CIE
Hf Scientific, Inc.
Chemistry · 130d
Cleared Mar 13, 1987
RING UPM TOTAL HIP REPLACEMENT
K864515 · KWA
Downs Surgical , Ltd.
Orthopedic · 116d
Cleared Mar 13, 1987
SUNGLASSES
K864543 · HQY
Image of Hawaii
Ophthalmic · 114d
Cleared Mar 13, 1987
S&W ELECTRODE TYPES 888, 844, 988 AND 944
K864586 · DRX
S & W Medico Teknik
Cardiovascular · 112d
Cleared Mar 13, 1987
TDXR CANNABINOIDS
K864751 · LDJ
Abbott Laboratories
Chemistry · 98d
Cleared Mar 13, 1987
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER
K864872 · JGS
Medica Corp.
Chemistry · 91d
Cleared Mar 13, 1987
BACPAC (TM), MODEL 6500
K864968 · GZJ
Medical Devices, Inc.
Neurology · 81d
Cleared Mar 13, 1987
PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER
K865011 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 80d
Cleared Mar 13, 1987
THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT
K865071 · JLW
Immuchem Corp.
Chemistry · 74d
Cleared Mar 13, 1987
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
K870025 · KMS
American Research Products Co.
Chemistry · 67d
Cleared Mar 13, 1987
THE SCREENER GSI 55 ABR SCREENER
K870030 · GWJ
Grason-Stadler, Inc.
Neurology · 67d
Cleared Mar 13, 1987
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106 · JHI
Diagnostic Products Corp.
Chemistry · 60d
Cleared Mar 13, 1987
PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG
K870166 · FNJ
George C. Kuhn
General Hospital · 58d