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
158545–158568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1983
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
K823352 · JJY
American Dade
Chemistry · 90d
Cleared Feb 07, 1983
KINEMATIC II KNEE SYSTEM
K823420 · KRO
Howmedica Corp.
Orthopedic · 84d
Cleared Feb 07, 1983
AUTO-TENS MODEL I DISPOS. SINGLE CHAN
K823467 · GZJ
Cbc Corp.
Neurology · 80d
Cleared Feb 07, 1983
101 UNIVERSAL ENDOPROSTHESIS
K823482 · KWY
Intermedics Orthopedics
Orthopedic · 76d
Cleared Feb 07, 1983
MYELOGRAPHY NEEDLE
K823693 · FMI
Ocean Medical Products, Ltd.
General Hospital · 61d
Cleared Feb 07, 1983
BEL BLOOD LEVEL DETECTOR
K823712 · DTW
R. Scott Bell
Cardiovascular · 59d
Cleared Feb 07, 1983
SINGLE ACCESS DEVICE (SSAD)
K823715 · KOC
Samaritan Hospital
Gastroenterology & Urology · 59d
Cleared Feb 07, 1983
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP
K823718 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 59d
Cleared Feb 07, 1983
ET-3 EMERGENCY TRANSPORT VENTILATOR
K823861 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 47d
Cleared Feb 07, 1983
GLUCOSE-6-PHOSPHATE DEHYDROGENASE
K823900 · KQE
Alladin Diagnostic, Inc.
Toxicology · 39d
Cleared Feb 07, 1983
MICRO JOIN, CROWN & BRIDGE ADHESIVE
K823935 · EMA
Sci-Pharm, Inc.
Dental · 40d
Cleared Feb 07, 1983
ACETAMIDE AGAR
K830020 · JSH
Gibco Laboratories Life Technologies,...
Microbiology · 34d
Cleared Feb 07, 1983
DISPOSABLE CYSTOTOME
K830040 · HNY
Contemporary Surgical Systems, Inc.
Ophthalmic · 31d
Cleared Feb 07, 1983
MODEL HI-FLO2 OXYGEN RICH AIR SUPPLY
K830046 · CAW
Greene & Kellogg, Inc.
Anesthesiology · 28d
Cleared Feb 07, 1983
SHUR GEL
K830083 · ELW
Columbus Dental Mfg. Co.
Dental · 27d
Cleared Feb 07, 1983
DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR
K830090 · JXL
Hudson Oxygen Therapy Sales Co.
Neurology · 27d
Cleared Feb 07, 1983
CONTINUOUS ANATOMICAL PASSIVE EXERCISER
K830122 · BXB
Zimmer, Inc.
Physical Medicine · 27d
Cleared Feb 07, 1983
PARAMOUNT THYROXINE ASSAY
K830136 · KLI
Syva Co.
Chemistry · 25d
Cleared Feb 07, 1983
CALIBRATOR A
K830137 · JIS
Hi Chem, Inc.
Chemistry · 25d
Cleared Feb 07, 1983
TANDEM E GCG VISUAL END POINT INNUMOENZ
K830138 · JHI
Hybritech, Inc.
Chemistry · 25d
Cleared Feb 07, 1983
SIGMA 300 GAS CHROMATROGRAPH
K830147 · KZQ
The Perkin-Elmer Corp.
Toxicology · 21d
Cleared Feb 07, 1983
OREXAS POTENTEST
K830158 · LIL
Orexas Medical Corp.
Gastroenterology & Urology · 20d
Cleared Feb 07, 1983
DORC ADJUSTABLE IMAGE CONTACTS
K830169 · HKS
Jedmed Instrument Co.
Ophthalmic · 20d
Cleared Feb 07, 1983
RIASSIST RAST DATA REDUCTION/QUALITY
K830170 · DHB
Ventrex Laboratories, Inc.
Chemistry · 20d