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
153385–153408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1984
OHIO WASTE GAS SCAVENGING INTERFACE
K842003 · CBN
Ohio Medical Products
Anesthesiology · 7d
Cleared May 22, 1984
DILATION BALLOON CATHETER
K834413 · FGE
Hobbs Medical, Inc.
Gastroenterology & Urology · 159d
Cleared May 22, 1984
I/A PROBE LINES
K834577
Frigitronics of Connecticut, Inc.
General & Plastic Surgery · 145d
Cleared May 22, 1984
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
K840221 · LLL
Zeus Scientific, Inc.
Microbiology · 124d
Cleared May 22, 1984
DISPOSABLE SCLERAL GLOBE PLUG
K840693 · LXP
Innovative Surgical Products, Inc.
Ophthalmic · 96d
Cleared May 22, 1984
PHACOEMULSIFICATION KITS
K840695 · HQC
Innovative Surgical Products, Inc.
Ophthalmic · 96d
Cleared May 22, 1984
MAKS CENTRAL DELIVERY SYS-11-200 ETC
K840859 · KOC
Erika, Inc.
Gastroenterology & Urology · 88d
Cleared May 22, 1984
CENTAURI CT SCANNER
K840860 · JAK
Technicare Corp.
Radiology · 88d
Cleared May 22, 1984
AMRESCO E4A REAGENT SET
K840868 · JJE
American Research Products Co.
Chemistry · 85d
Cleared May 22, 1984
ELECTRO-PALATE
K840892 · ESE
Cisko Systems
Ear, Nose, Throat · 85d
Cleared May 22, 1984
LINEAR CLOUD TONOMETER
K841089 · LCH
Linear Tonometers, Inc.
Chemistry · 70d
Cleared May 22, 1984
TAGO DIFFU-GEN C-REACTIVE PROTEIN
K841265 · DCN
Tago, Inc.
Chemistry · 57d
Cleared May 22, 1984
C-17
K841268 · EBF
Pentron Corp.
Dental · 57d
Cleared May 22, 1984
C-19
K841269 · EBF
Pentron Corp.
Dental · 57d
Cleared May 22, 1984
GASTROSTOMY FEEDING TUBE
K841330 · KNT
Microvasive
Gastroenterology & Urology · 50d
Cleared May 22, 1984
SCOTTS TAP WATER SUBSTITUTE 7
K841423 · JCC
Reagent Laboratory, Inc.
Pathology · 47d
Cleared May 22, 1984
NUMBER 21 R/R SYSTEM
K841457 · KLE
Pentron Corp.
Dental · 43d
Cleared May 22, 1984
NUMBER 20 R/L SYSTEM
K841458 · KLE
Pentron Corp.
Dental · 43d
Cleared May 22, 1984
KODAK EKTACHEM DT 60 ANALYZER
K841503 · JJE
Eastman Kodak Company
Chemistry · 42d
Cleared May 22, 1984
CONCENTRATE CONDUCTIVITY METER
K841543 · FKQ
Renal Systems, Inc.
Gastroenterology & Urology · 36d
Cleared May 22, 1984
SIGMA PROCEDURE 16-UV
K841555 · CFR
Sigma Chemical Co.
Chemistry · 36d
Cleared May 22, 1984
ORTHO MICROWELL READER
K841557 · JJQ
Ortho Diagnostic Systems, Inc.
Chemistry · 36d
Cleared May 22, 1984
TECHNICON RA-1000 SYS T4-THYROXINE
K841576 · KLI
Technicon Instruments Corp.
Chemistry · 35d
Cleared May 22, 1984
SUN-LITE WHITE SPOT
K841588 · KYT
Suncoast Medical Manufacturers, Inc.
General Hospital · 34d