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
164593–164616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1981
HEMOGLOBIN ELECTROPHORESIS CONTROL
K810919 · JBD
Isolab, Inc.
Chemistry · 17d
Cleared Apr 23, 1981
NATURALYTE BICARBONATE DIALYSATE CONCEN.
K810925 · KPO
Erika, Inc.
Gastroenterology & Urology · 17d
Cleared Apr 23, 1981
MASS SPECTROMETER-MEDSPECT II
K810938 · DOP
Allied Healthcare Products, Inc.
Toxicology · 16d
Cleared Apr 23, 1981
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.
K810939 · BTT
Allied Healthcare Products, Inc.
Anesthesiology · 16d
Cleared Apr 23, 1981
PENILE ERECTION MONITOR
K810944 · LIL
Medical Monitoring Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Apr 23, 1981
REAGENTS FOR QUANT. ENZYMATIC DETER.-TR.
K810951
Mid Tech, Inc.
Chemistry · 16d
Cleared Apr 23, 1981
MODEL 533 PHOTOTHERAPY UNIT
K810953 · LBI
Narco Air-Shields
General Hospital · 16d
Cleared Apr 23, 1981
NASOPHARYNGEAL AIRWAY
K810960 · BTQ
Vesta, Inc.
Anesthesiology · 15d
Cleared Apr 23, 1981
IN-VITRO TBG RADIOIMMUNOASSAY TEST
K810967 · CEE
Clinical Assays, Inc.
Chemistry · 15d
Cleared Apr 23, 1981
BCD-HPP41C INTERFACE
K810968 · JQP
Dynatech Corp.
Immunology · 14d
Cleared Apr 23, 1981
OHIO NONCONDUCTIVE RBS TYPE FACE MASK
K810990 · BSJ
Ohio Medical Products
Anesthesiology · 10d
Cleared Apr 23, 1981
WORTHINGTON CK (NAC) REAGENT SET
K810997 · JHS
Worthington Diagnostic Systems
Chemistry · 10d
Cleared Apr 23, 1981
ANA TEST KIT
K811022 · DHN
Immuno-Diagnostic Products, Inc.
Immunology · 8d
Cleared Apr 21, 1981
ANTHRON CATHETER SET
K802918 · FOZ
National Catheter Co. Div. Mallinckrodt
General Hospital · 153d
Cleared Apr 21, 1981
PEDICAT*
K810049 · KMJ
Pollak (Intl.), Ltd.
General Hospital · 98d
Cleared Apr 21, 1981
K-Y LUBRICATING JELLY
K810310 · KMJ
Johnson & Johnson Professionals, Inc.
General Hospital · 75d
Cleared Apr 21, 1981
SUCTION COLLECTION BOTTLE, DISPOSABLE
K810574 · KDQ
Harvard Laboratories
General Hospital · 49d
Cleared Apr 21, 1981
SECURE
K810715 · DYH
Sci-Pharm, Inc.
Dental · 35d
Cleared Apr 21, 1981
DENTAL PORCELAIN POWDER
K810822 · EIH
Coors Biomedical Co.
Dental · 28d
Cleared Apr 21, 1981
INTERFACE 20 MICRON TRANSFUSION BLD. F.
K810855 · CAK
Abbott Laboratories
Hematology · 22d
Cleared Apr 21, 1981
WATER PIK ORAL HYGIENE CENTER
K810864 · EFS
Teledyne, Inc.
Dental · 21d
Cleared Apr 21, 1981
CASTLE PROCEDURE AND RITTER EXAM. TABLES
K810900 · LGX
Sybron Corp.
General Hospital · 18d
Cleared Apr 21, 1981
LEE ENDOFILL, ROOT CANAL FILLING RESIN
K810923 · KIF
Lee Pharmaceuticals
Dental · 15d
Cleared Apr 21, 1981
NORFOLK/NORWICH PRESSURE INFUSION BOX
K810954 · KZD
Medical Innovations Corp.
General Hospital · 14d