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
155761–155784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1983
SERUM CHOLINESTERASE REAGENT SET
K833062 · DLI
Sterling Biochemical, Inc.
Chemistry · 78d
Cleared Nov 25, 1983
REAGENT SET TRIGLYCERIDES GPO
K833082 · CDT
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Nov 25, 1983
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU
K833153 · JJF
Nova Biomedical Corp.
Chemistry · 71d
Cleared Nov 25, 1983
QUIDEL HCG ENZYME IMMUNOASSAY KIT
K833156 · JHJ
Quidel Corp.
Chemistry · 70d
Cleared Nov 25, 1983
POTASSIUM ELECTRODE TIP ASSAMBLY-K-
K833159 · CEM
Hi Chem, Inc.
Chemistry · 70d
Cleared Nov 25, 1983
TOOTH SLOOTH
K833338 · EJB
Joel Lander D.D.S.
Dental · 59d
Cleared Nov 25, 1983
EARLY PREGNANCY DETECTION TEST KIT
K833466 · LCX
Quidel Corp.
Chemistry · 50d
Cleared Nov 25, 1983
HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK
K833665 · HYF
J.S. Medical Assoc.
Hematology · 38d
Cleared Nov 25, 1983
QUICK STAIN WRIGHT'S GIEMSA W/BUFF
K833677 · HYF
J.S. Medical Assoc.
Hematology · 38d
Cleared Nov 25, 1983
HEMATOLOGY WRIGHT'S STAIN PACK
K833678 · IAF
J.S. Medical Assoc.
Hematology · 38d
Cleared Nov 22, 1983
DONALDSON VENT TUBE
K823910 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 329d
Cleared Nov 22, 1983
OXYGEN CONCENTRATOR RESPIRATORY SUPPOR
K831819 · CAW
Eagle Medical Equipment Co.
Anesthesiology · 169d
Cleared Nov 22, 1983
GASLINE FILTER, #EC-GLF SERIES
K832935 · CAH
Gish Biomedical, Inc.
General Hospital · 84d
Cleared Nov 22, 1983
STAODYN EMS/PLUS
K832988 · IPF
Staodynamics, Inc.
Physical Medicine · 82d
Cleared Nov 22, 1983
TSH RIA
K833910 · ETD
Syncor Intl. Corp.
Chemistry · 8d
Cleared Nov 21, 1983
CAPNOMETER W/NEW AIRWAY ADAPTER 47210A
K831447 · CCK
Hewlett-Packard Co.
Anesthesiology · 200d
Cleared Nov 21, 1983
POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE
K831984 · DGO
Diagnostic Reagent Tech.
Microbiology · 154d
Cleared Nov 21, 1983
PERSONAL AMPLIFIER
K832168 · ESD
Electone, Inc.
Ear, Nose, Throat · 138d
Cleared Nov 21, 1983
POLYSTYRENE MICROTITER PLATE IMMUNO-
K832344 · DHB
Diagnostic Reagent Tech.
Immunology · 131d
Cleared Nov 21, 1983
OPTHALMIC ENDOSCOPE
K832405
Cilco, Inc.
Neurology · 123d
Cleared Nov 21, 1983
DIACROM *PLG
K832591 · DDX
Wellcome Diagnostics
Immunology · 111d
Cleared Nov 21, 1983
TOP VENULA I.V. CATHETER SET
K832624 · FOZ
Top Surgical Manufacturers Co.
General Hospital · 109d
Cleared Nov 21, 1983
INNOVATIVE HEARING CORP. #IHC 1000
K832633 · ESD
Innovative Hearing Corp.
Ear, Nose, Throat · 109d
Cleared Nov 21, 1983
ALPHA-I
K832642 · LHC
Johnson Flexgroup
General Hospital · 109d