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
160393–160416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1982
ALT ENZYME ASSAY KIT
K821946 · CKA
Travenol Laboratories, S.A.
Chemistry · 20d
Cleared Jul 20, 1982
Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED
K821950 · DIF
Travenol Laboratories, S.A.
Toxicology · 20d
Cleared Jul 20, 1982
CARDIO-RESPIRATORY MONITOR MODEL CR-1
K821959 · DRT
Electromed Intl., Ltd.
Cardiovascular · 20d
Cleared Jul 20, 1982
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K821965 · LAT
Immunalysis Corporation
Chemistry · 18d
Cleared Jul 20, 1982
VALULINE* AMALGAM ALLOY
K821971 · EJJ
Johnson & Johnson Professionals, Inc.
Dental · 14d
Cleared Jul 20, 1982
HEARING AID VARIOUS MODELS
K821972 · ESD
Panasonic Co. Div. Matsu Elec. Corp....
Ear, Nose, Throat · 18d
Cleared Jul 20, 1982
Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.
K821973 · DIF
Travenol Laboratories, S.A.
Toxicology · 18d
Cleared Jul 20, 1982
ANGIOGRAPHY KIT
K821976 · DQO
Mallinckrodt Critical Care
Cardiovascular · 14d
Cleared Jul 20, 1982
LAVAGING CATHETERS
K822061 · OCX
American Endoscopy, Inc.
Gastroenterology & Urology · 7d
Cleared Jul 20, 1982
ULTRASOUND AUTO SECTOR CARDIAC MODULE
K827610
Technicare Corp.
Radiology · 35d
Cleared Jul 20, 1982
TECHNICARE ULTRASOUND AUTO SECTOR B-SCAN ARM OPTION
K827652
Technicare Corp.
Radiology · 22d
Cleared Jul 19, 1982
PERCUTANEOUS TRACHEOSTOMY DEVICE
K821821
Frederic J. Toye, M.D.
Gastroenterology & Urology · 27d
Cleared Jul 16, 1982
PREG-PHILE B
K821676 · JHJ
Bio Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jul 16, 1982
AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR
K821895 · EBF
American Midwest
Dental · 18d
Cleared Jul 16, 1982
ORTHO CLASSICAL PATHWAY COMPL. TEST
K821898 · DBA
Ortho Diagnostic Systems, Inc.
Immunology · 18d
Cleared Jul 16, 1982
SYVA ADVANCE STANDARDIZATION KIT #2
K821937 · JIS
Syva Co.
Chemistry · 17d
Cleared Jul 16, 1982
SYVA ADVANCE STANDARDIZATION KIT #3
K821938 · JIS
Syva Co.
Chemistry · 17d
Cleared Jul 16, 1982
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY
K821945 · KLT
American Diagnostic Corp.
Toxicology · 17d
Cleared Jul 16, 1982
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K821966 · CAD
Ohio Medical Products
Anesthesiology · 14d
Cleared Jul 16, 1982
ACETAMINOPHEN STAT-PAK REAGENT SET
K821969 · LDP
Clin Tech Diagnostics Corp.
Toxicology · 15d
Cleared Jul 14, 1982
ORTHO SPECTRUM III & ORTHO-MUNE OK
K820643 · LIZ
Ortho Diagnostic Systems, Inc.
Hematology · 128d
Cleared Jul 14, 1982
CORNEA PERSERVATION UNIT
K821170 · LYX
Xytex Corp.
Ophthalmic · 79d
Cleared Jul 14, 1982
SGPT REAGENT SET
K821207 · CKD
Omega Medical Electronics
Chemistry · 78d
Cleared Jul 14, 1982
SGOT REAGENT SET
K821209 · CIQ
Omega Medical Electronics
Chemistry · 78d