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
155305–155328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1984
TRACH MATE
K834265 · JAY
Tempe Biomedical, Inc.
Anesthesiology · 27d
Cleared Jan 04, 1984
BI-PLANE DIGITAL FLUOROGRAPHY DFX7000
K834286 · JAA
Adac Laboratories
Radiology · 40d
Cleared Jan 03, 1984
THERAPEUTIC EXCHANGE SYSTEM
K831423 · LQQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 245d
Cleared Jan 03, 1984
PLASTIC LEG BAG
K831530 · KNX
Forever-Dry, Inc.
Gastroenterology & Urology · 236d
Cleared Jan 03, 1984
COVERUPS
K831703 · NAD
The Urology Group
General & Plastic Surgery · 223d
Cleared Jan 03, 1984
BARD ABSORPTION DRESSING
K831710 · FRO
C.R. Bard, Inc.
General & Plastic Surgery · 221d
Cleared Jan 03, 1984
ELECTROCARDIOGRAPH MACHINES, W/ANALYZ
K832092
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Jan 03, 1984
DRUMTO STAPES PROSTHESIS
K832540 · ETB
Humboldt Products
Ear, Nose, Throat · 158d
Cleared Jan 03, 1984
ULTRAFILTRATION CONTROLLER
K832547 · KDI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 155d
Cleared Jan 03, 1984
RAAF CATHETER REPAIR KIT
K832580 · LJS
Quinton, Inc.
General Hospital · 154d
Cleared Jan 03, 1984
NON-INVASIVE CLINICAL VASCULAR LAB
K832679 · DQC
Life Sciences Manufacturing, Inc.
Cardiovascular · 147d
Cleared Jan 03, 1984
REPAIR KITS FOR RIGHT ATRIAL CATH
K832774 · LJS
Quinton, Inc.
General Hospital · 140d
Cleared Jan 03, 1984
SHUFFIELD TECH ENEMA TIP
K832960 · FCE
Shuffield Tech Co.
Gastroenterology & Urology · 126d
Cleared Jan 03, 1984
CEPHALOMETER & FIXATOR
K833006 · EAG
Modern Systems, Inc.
Radiology · 119d
Cleared Jan 03, 1984
O.B. TAMPONS
K833179 · HEB
Personal Products Co.
Obstetrics & Gynecology · 106d
Cleared Jan 03, 1984
INTERIM TEMP. CROWN & BRIDGE RESIN
K833261 · EBG
Coe Laboratories, Inc.
Dental · 102d
Cleared Jan 03, 1984
SATIN CAST ECONOCAST
K833287 · EIS
Genesis Industries, Inc.
Dental · 103d
Cleared Jan 03, 1984
C & B 40 PENTRO C & B40
K833290 · EIS
Genesis Industries, Inc.
Dental · 103d
Cleared Jan 03, 1984
NORMAL GOAT SERUM
K833318 · DHX
Biosan Laboratories, Inc.
Immunology · 99d
Cleared Jan 03, 1984
ARMBOARD
K833559 · KPR
Mtd, Inc.
Radiology · 90d
Cleared Jan 03, 1984
HC PLUS
K833563 · JPK
Coulter Electronics, Inc.
Hematology · 83d
Cleared Jan 03, 1984
ANTRUM & ATTIC MIRROR
K833601 · KAI
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
ROLLER KNIFE-TRANSVERSE -SAGITTAL
K833602 · JYO
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
SCISSORS SHEA BELLUCC
K833603 · JZB
Microtek Medical, Inc.
Ear, Nose, Throat · 83d