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
141769–141792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1987
TISSUE-EQUIVALENT BREAST SIMULATOR
K865100 · IXF
Computerized Imaging Reference...
Radiology · 13d
Cleared Jan 12, 1987
ADDITIONAL MODEL TO CANON UNIVERSAL STAND
K870048 · KPX
Canon USA, Inc.
Radiology · 6d
Cleared Jan 09, 1987
TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS
K861202 · JJY
Nms Pharmaceuticals, Inc.
Chemistry · 284d
Cleared Jan 09, 1987
MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE
K862865 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 164d
Cleared Jan 09, 1987
MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE
K862866 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 164d
Cleared Jan 09, 1987
SONOLAYER-L, SAL-77B
K863947 · IYO
Toshiba Medical Systems
Radiology · 91d
Cleared Jan 09, 1987
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
K863999 · LCX
Leeco Diagnostics, Inc.
Chemistry · 87d
Cleared Jan 09, 1987
SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)
K864267 · DPM
Millipore Corp.
Chemistry · 72d
Cleared Jan 09, 1987
UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS
K864277 · ESD
Unimax Hearing Instruments
Ear, Nose, Throat · 71d
Cleared Jan 09, 1987
TERUMO OVATION SPECTROPHOTOMETER
K864285 · JJQ
Terumo Medical Corp.
Chemistry · 71d
Cleared Jan 09, 1987
IC MICROASSAY
K864312 · DAK
Diamedix Corp.
Immunology · 67d
Cleared Jan 09, 1987
CYTOLOGY BRUSHES
K864323 · HHT
Medical Packaging Corp.
Obstetrics & Gynecology · 67d
Cleared Jan 09, 1987
PACHYMETER SYSTEM V
K864336 · IYO
CooperVision, Inc.
Radiology · 66d
Cleared Jan 09, 1987
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
K864373 · LCX
Unipath , Ltd.
Chemistry · 65d
Cleared Jan 09, 1987
MAXI-TAN DEVICE
K864546 · FTC
National Biological Corp.
General & Plastic Surgery · 51d
Cleared Jan 09, 1987
MOBIL 02
K864680 · BTI
Roman Laboratories, Inc.
Anesthesiology · 38d
Cleared Jan 09, 1987
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K864741 · CIC
Tech-Co, Inc.
Chemistry · 36d
Cleared Jan 09, 1987
WAKO(TM) AUTOKIT GPT
K864850 · CKA
Wako Chemicals USA, Inc.
Chemistry · 30d
Cleared Jan 09, 1987
SPECULUM, VAGINAL, METAL FIBEROPTIC
K864865 · HDG
Luxtec Corp.
Obstetrics & Gynecology · 29d
Cleared Jan 09, 1987
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
K864894 · DMT
Em Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jan 09, 1987
ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
K864966 · CGF
Diagnostics Biochem Canada, Inc.
Chemistry · 18d
Cleared Jan 09, 1987
GENERAL PURPOSE CENTRIFUGE
K864974 · JQC
Norfolk Scientific, Inc.
Chemistry · 21d
Cleared Jan 09, 1987
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
K865014 · DGR
Bio-Rad
Immunology · 17d
Cleared Jan 08, 1987
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
K864553 · KLT
Em Diagnostic Systems, Inc.
Toxicology · 50d