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
143593–143616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1986
POLYESTER SPONGE PATTIE
K862494 · HBA
American Silk Sutures, Inc.
Neurology · 29d
Cleared Jul 30, 1986
TREACE MEDICAL MICRO INSTRUMENT WIPE
K862582
Treace Medical, Inc.
General & Plastic Surgery · 23d
Cleared Jul 30, 1986
PACEMAKER LEAD ADAPTER
K862656 · DTD
Cordis Corp.
Cardiovascular · 16d
Cleared Jul 30, 1986
TRACHEOSTOMY CARE TRAY
K862663 · LRQ
Welmed Systems, Inc.
General & Plastic Surgery · 16d
Cleared Jul 30, 1986
JEDMED CCD CAMERA SYSTEM
K862664 · FWD
Jedmed Instrument Co.
General & Plastic Surgery · 16d
Cleared Jul 30, 1986
TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
K862696 · HBT
Downs Surgical , Ltd.
General & Plastic Surgery · 15d
Cleared Jul 30, 1986
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
K862702 · LPH
Depuy, Inc.
Orthopedic · 15d
Cleared Jul 30, 1986
HAND MIRROR (ENDOSCOPE)
K862717 · GCO
Simpson/Basye, Inc.
Gastroenterology & Urology · 13d
Cleared Jul 29, 1986
RIGHT-DAY URINARY LH (EIA)
K860538 · CEP
Leeco Diagnostics, Inc.
Chemistry · 167d
Cleared Jul 29, 1986
MILLAR PULSED DOPPLER VELOCIMETER
K860766 · DPW
Millar Instruments, Inc.
Cardiovascular · 148d
Cleared Jul 29, 1986
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703 · JHJ
Leeco Diagnostics, Inc.
Chemistry · 85d
Cleared Jul 29, 1986
DU PONT DRUG CALIBRATOR
K861786 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 82d
Cleared Jul 29, 1986
TWIN GOT-AST IFCC/GPT-ALT IFCC
K861792 · CKA
Boehringer Mannheim Corp.
Chemistry · 81d
Cleared Jul 29, 1986
OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40
K862061 · LYC
Coors Biomedical Co.
Dental · 60d
Cleared Jul 29, 1986
PANAVIA TC, AND PANAVIA OPAQUE
K862232 · EBF
Kuraray Co.
Dental · 48d
Cleared Jul 29, 1986
TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
K862247 · JHI
V-Tech, Inc.
Chemistry · 47d
Cleared Jul 29, 1986
IL 482 CO-OXIMETER
K862253 · JKS
Instrumentation Laboratory CO
Chemistry · 46d
Cleared Jul 29, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
K862255 · CFJ
Sterling Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 29, 1986
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS
K862262 · JHI
Serono Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 29, 1986
ANALYST ANALYTICAL TEST ROTORS
K862274 · CIC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 43d
Cleared Jul 29, 1986
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT
K862300 · JGM
Amresco, Inc.
Chemistry · 42d
Cleared Jul 29, 1986
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
K862506 · KIE
Millipore Corp.
Toxicology · 28d
Cleared Jul 29, 1986
LIQUID CHROMATOGRAPHY COLUMNS
K862541 · DPM
Supelco, Inc.
Toxicology · 26d
Cleared Jul 29, 1986
EMIT VALPROIC ACID ASSAY
K862652 · LEG
Syva Co.
Toxicology · 18d