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

Filters: Cleared only ×
176,076 results
157513–157536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1983
COAT-A-COUNT NO-EXTRACTION TESTOSTERONE
K831342 · CDZ
Diagnostic Products Corp.
Chemistry · 38d
Cleared Jun 02, 1983
MICROCAPILLARY INFUSION SYSTEM
K831347 · FFX
J.S. Biomedicals, Inc.
Gastroenterology & Urology · 38d
Cleared Jun 02, 1983
EMIT QST QUINIDINE ASSAY
K831355 · LBZ
Syva Co.
Toxicology · 37d
Cleared Jun 02, 1983
BOUNDARY HEADWEAR
K831357 · FYF
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 37d
Cleared Jun 02, 1983
BETA-PREG
K831361 · JHJ
Catheter Technology Corp.
Microbiology · 37d
Cleared Jun 02, 1983
TESTCORP ANA
K831365 · LKS
Catheter Technology Corp.
Microbiology · 37d
Cleared Jun 02, 1983
TESTCORP PREG
K831366 · JHJ
Catheter Technology Corp.
Microbiology · 37d
Cleared Jun 02, 1983
IGE RADIOIMMUNOASSAY KIT
K831377 · DGC
American Diagnostic Corp.
Chemistry · 36d
Cleared Jun 02, 1983
LITHOTOMY CHAIR #415
K831385 · GBB
Midmark Corp.
General & Plastic Surgery · 35d
Cleared Jun 02, 1983
GLASS FRAMES & COMPONENT PARTS
K831388 · HQZ
Anamar
Ophthalmic · 35d
Cleared Jun 02, 1983
AMES TDA N-ACETYL-PROCAINAMIDE TEST
K831399 · LAN
Miles Laboratories, Inc.
Immunology · 34d
Cleared Jun 02, 1983
AMES TDA PROCAINAMIDE TEST
K831400 · LAR
Miles Laboratories, Inc.
Immunology · 34d
Cleared Jun 02, 1983
MDT CHEMITEST SEE-THRU BAG
K831425 · FRG
Kenpak Converters, Inc.
General Hospital · 30d
Cleared Jun 02, 1983
EXTRASENSR ULTRAFILTRATION MONITOR
K831433 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 29d
Cleared Jun 02, 1983
DISPOSABLE STERILE FILTER SYSTEM
K831450 · LIB
Corning Medical & Scientific
Pathology · 28d
Cleared Jun 02, 1983
VENTRE/ZYME IGE KIT
K831485 · DGC
Ventrex Laboratories, Inc.
Immunology · 24d
Cleared Jun 02, 1983
TUB TRANSFER BENCH BK6481
K831541 · IKX
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared May 31, 1983
PZ-600 COMPUTERIZED AXIAL TOMOGRAPHY SCANNER
K837343
Phoenix Medical Electronics
Radiology · 92d
Cleared May 30, 1983
PC 2909A-HEALTH PULSE CONTROL STIMULATOR
K830747 · GZJ
J.A. Preston Corp.
Neurology · 82d
Cleared May 27, 1983
BARD URETERAL STENT
K823487 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 185d
Cleared May 27, 1983
AHR-3000 RE-USE ADAPTOR
K830190 · LIF
Colorado Medical, Inc.
Gastroenterology & Urology · 128d
Cleared May 27, 1983
SIEMENS-ELMA PULSE GENERATOR #718
K830344 · DXY
Burditt & Calkins-Siemens-Elema
Cardiovascular · 114d
Cleared May 27, 1983
COLORECTAL DILATOR
K830354 · FFP
Cleveland Medical Supply & Services
Gastroenterology & Urology · 113d
Cleared May 27, 1983
ANVIL RETRACTOR
K830585 · GAD
Twin City Surgical, Inc.
General & Plastic Surgery · 93d