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
171457–171480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1978
STIMULATOR, NERVE, TRANSCUTANEOUS
K781157
Medtech Intl., Inc.
Neurology · 77d
Cleared Sep 20, 1978
MERCURY DISP. CAPSULE
K781243 · DZS
Lee Pharmaceuticals
Dental · 100d
Cleared Sep 20, 1978
LUNG EXER. BAG, POST-OP, MODIFIED
K781245 · BWF
Dytek Corp.
Anesthesiology · 65d
Cleared Sep 20, 1978
DIGITAL PANEL METER
K781255 · DRT
Rae Medical Corp.
Cardiovascular · 61d
Cleared Sep 20, 1978
CATHODE RAY TUBE MED. DISPLAY
K781256 · DXJ
Rae Medical Corp.
Cardiovascular · 61d
Cleared Sep 20, 1978
PAB CONVENIENCE TRAY
K781264 · GAA
Waters Assoc., Inc.
General & Plastic Surgery · 58d
Cleared Sep 20, 1978
CARDIOPNEUMOGRAPH
K781292 · DRT
Street Electronics Corp.
Cardiovascular · 57d
Cleared Sep 20, 1978
T.E.D. SEQUENTIAL COMPRESSION SLEEVES
K781357 · JOW
Kendall Research Center
Cardiovascular · 43d
Cleared Sep 20, 1978
SEQUENTIAL CUFF INFLATION DEVICE
K781358 · JOW
Medasonics, Inc.
Cardiovascular · 43d
Cleared Sep 20, 1978
MS-2 AUTOMATED URINE SCREENING SYSTEM
K781370 · JXA
Abbott Laboratories
Microbiology · 43d
Cleared Sep 20, 1978
BONE MARROW ASPIRATION KIT
K781371 · GAA
Ferris Mfg. Corp.
General & Plastic Surgery · 43d
Cleared Sep 20, 1978
OSTOMY APPLIANCE W/DEODORIZING FILTER
K781373 · EXB
Hollister, Inc.
Gastroenterology & Urology · 44d
Cleared Sep 20, 1978
COMFORM ABSORBANT INCONTINENCE PADS
K781375 · EYQ
Kimberly-Clark Corp.
Gastroenterology & Urology · 42d
Cleared Sep 20, 1978
INSTA-PULSE HEART RATE MONITOR
K781387 · DRT
Bio Sig Instruments, Inc.
Cardiovascular · 41d
Cleared Sep 20, 1978
TECA MODEL B9 ELECTROMYOGRAPH
K781399 · IKN
Teca, Inc.
Neurology · 36d
Cleared Sep 20, 1978
HEMOVAC TUBING MATERIAL CHANGE
K781400 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 36d
Cleared Sep 20, 1978
CORNEAL CUTTER AND ACCESSORIES
K781411 · HRH
Codman & Shurtleff, Inc.
Ophthalmic · 36d
Cleared Sep 20, 1978
PRECISION GAS MIXER
K781417 · LCH
Medicor USA , Ltd.
Chemistry · 35d
Cleared Sep 20, 1978
BIOSCAN E12
K781421 · JJS
Clinifax Industries, Ltd.
Chemistry · 34d
Cleared Sep 20, 1978
LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA
K781454 · CHW
Union Carbide Corp.
Chemistry · 29d
Cleared Sep 20, 1978
FOLEY CATHETERS
K781457 · KOD
Intermed, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 20, 1978
MICROSURGICAL KNIVES, 20, 30, 45
K781465 · HNN
Codman & Shurtleff, Inc.
Ophthalmic · 26d
Cleared Sep 20, 1978
TILLMAN HIPSURFACE REPLACEMENT
K781490 · KXA
Waldemar Link GmbH & Co. KG
Orthopedic · 23d
Cleared Sep 20, 1978
SILASTIC U-TUBE KIT
K781526 · GBO
Dow Corning Corp. Healthcare...
General & Plastic Surgery · 15d