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
143665–143688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1986
SET CANAL SEALER PASTE
K862129 · EKM
Endo Technic Corp.
Dental · 48d
Cleared Jul 22, 1986
ALPHA ALL-IN-THE-EAR HEARING AID
K862169 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 43d
Cleared Jul 22, 1986
PHONIC EAR PE 602 PPCS
K862229 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 41d
Cleared Jul 22, 1986
DEN-MAT DENTIN LINK
K862449 · EBF
Den-Mat Corp.
Dental · 25d
Cleared Jul 22, 1986
MX MOBILE X-RAY SYSTEM
K862452 · IZL
Philips Medical Systems (Cleveland),...
Radiology · 25d
Cleared Jul 22, 1986
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590 · EBD
3M Company
Dental · 15d
Cleared Jul 22, 1986
TORAY FILTRYZER DIALYZER, B1-2.0.
K862693 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 11d
Cleared Jul 21, 1986
MANIQUICK PEDICURE & MANICURE SET
K861360
Quicklime Maniquick
General & Plastic Surgery · 102d
Cleared Jul 21, 1986
ENZYGNOST ANTI-CMV IGM TEST
K861363 · LKQ
Behring Diagnostics, Inc.
Microbiology · 102d
Cleared Jul 21, 1986
RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT
K861790 · DWF
Research Medical, Inc.
Cardiovascular · 73d
Cleared Jul 21, 1986
KOAGULAB* M COAGULATION SYSTEM
K862537 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 19d
Cleared Jul 21, 1986
LITE TOUCH GELFOAM INSERT
K862583
Treace Medical, Inc.
General & Plastic Surgery · 14d
Cleared Jul 18, 1986
PULSAR NEUROSTIMULATOR
K852061 · GZJ
Andromeda Research, Inc.
Neurology · 435d
Cleared Jul 18, 1986
THE NAVIGATOR STEERABLE GUIDE WIRE
K860430 · DQX
Meadox Surgimed, Inc.
Cardiovascular · 164d
Cleared Jul 18, 1986
SONOLAYER-L, SAL-38A, WITH SCANNER SAL-38AS
K860531 · ITX
Toshiba Medical Systems
Radiology · 156d
Cleared Jul 18, 1986
MICRON, MICROVASCULAR DOPPLER
K860651 · DPW
Diagnostic Electronics Corp.
Cardiovascular · 147d
Cleared Jul 18, 1986
MODEL 545-45 LASER FOR EAR, NOSE & THROAT
K860975 · EWG
Britt Corp., Inc.
Ear, Nose, Throat · 126d
Cleared Jul 18, 1986
ENTUBE TM, ENTERAL FEEDING TUBE
K861427 · KNT
Entech, Inc.
Gastroenterology & Urology · 93d
Cleared Jul 18, 1986
MODEL 450 INFRARED IMAGING SYSTEM
K861534 · LHQ
Mitek , Inc.
Radiology · 85d
Cleared Jul 18, 1986
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
K861544 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 85d
Cleared Jul 18, 1986
IMPLANTABLE ELECTRODE LEAD, MODEL 030-436
K861767 · DTB
Telectronics, Inc.
Cardiovascular · 72d
Cleared Jul 18, 1986
COBE ACCESSORY INTERFACE MODULE (AIM)
K861860 · KRL
Cobe Laboratories, Inc.
Cardiovascular · 65d
Cleared Jul 18, 1986
ACUSON L382 AND L312 TRANSDUCERS
K861866 · JOP
Acuson Computed Sonography
Cardiovascular · 66d
Cleared Jul 18, 1986
MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM
K861994 · KPR
Medicor USA , Ltd.
Radiology · 56d