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
151897–151920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1984
LEECO CORTISOL-QUANT
K843384 · CGR
Leeco Diagnostics, Inc.
Chemistry · 31d
Cleared Sep 28, 1984
EMIT 700 CONTROL SET B
K843508 · DIF
Syva Co.
Toxicology · 22d
Cleared Sep 28, 1984
PDA CHOLESTEROL
K843510 · CHH
Abbott Laboratories
Chemistry · 22d
Cleared Sep 28, 1984
GLUCOSE OXIDASE ENZYMATIC REAGENT SET
K843528 · CGA
Livonia Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 28, 1984
PDA GLUCOSE
K843541 · CFR
Abbott Laboratories
Chemistry · 21d
Cleared Sep 28, 1984
PRECISET AMMONIA
K843569 · JJX
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Sep 28, 1984
QUALIFY I & II AMER. MONITOR 2009 & 2010
K843611 · JJY
American Monitor Corp.
Chemistry · 15d
Cleared Sep 28, 1984
FIAX 420 DILUTOR
K843621 · JQW
Intl. Diagnostic Technology
Chemistry · 14d
Cleared Sep 28, 1984
MATCHED COMPONENT SET FOR RADIOIMMUNO-
K843635 · JKC
Cambridge Medical Technology
Chemistry · 11d
Cleared Sep 28, 1984
SYSTEMATE A AMYLASE HEM 67204
K843645 · CIJ
Em Diagnostic Systems, Inc.
Chemistry · 11d
Cleared Sep 27, 1984
MEDICALEX
K833377 · GEA
Medicalex
General & Plastic Surgery · 364d
Cleared Sep 27, 1984
MK 700 ULTRASOUND SYSTEM
K842093 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 126d
Cleared Sep 27, 1984
BOSWORTH SUPER BOND DENTAL ADHESIVE
K842448 · DYH
Harry J. Bosworth Co.
Dental · 97d
Cleared Sep 27, 1984
CLEAR LINER
K842576 · EBI
Harry J. Bosworth Co.
Dental · 86d
Cleared Sep 27, 1984
ANDROSTENEDIONE BY RIA
K842960 · CIZ
Radioassay Systems Laboratories, Inc.
Chemistry · 62d
Cleared Sep 27, 1984
FLEXI-POST
K843018 · ECR
Essential Dental Systems, Inc.
Dental · 57d
Cleared Sep 27, 1984
COMMAND ULTRASEAL PIT & FISSURE SEALANT
K843024 · EBC
Kerr Corporation (Danbury)
Dental · 57d
Cleared Sep 27, 1984
KERR GELLED PHOSPHORIC ACID ETCHANT
K843026 · EBF
Kerr Corporation (Danbury)
Dental · 57d
Cleared Sep 27, 1984
RELIANCE TREATMENT CABINET
K843046 · ETF
F. & F. Koenigkramer
Ear, Nose, Throat · 56d
Cleared Sep 27, 1984
INSTRUMENTS FOR MICRO ANASTOMOSIS
K843100 · GAD
Downs Surgical , Ltd.
General & Plastic Surgery · 51d
Cleared Sep 27, 1984
STABILIZING RETAINER
K843143 · EJF
Dental Advancements, Inc.
Dental · 48d
Cleared Sep 27, 1984
ANTERIOR ALVEOLAR RIDGE SIZER
K843153 · LYC
Interpore Intl.
Dental · 48d
Cleared Sep 27, 1984
TPS SCREW DENTAL IMPLANTS
K843218 · DZE
Artech Corp.
Dental · 43d
Cleared Sep 27, 1984
FLOW CONTROLLER
K843223 · BTM
Precision Medical, Inc.
Anesthesiology · 42d