FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
156673–156696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 27, 1983
DIRECTIGEN NEISSERIA MENINGITIDIS
K830646
Bd Becton Dickinson Vacutainer...
Microbiology · 87d
Cleared May 27, 1983
PORTABLE OXYGEN SYSTEM
K830844 · CAN
Puritan Bennett Corp.
Anesthesiology · 71d
Cleared May 27, 1983
STOMACH TUBE
K830985 · KNT
Medovations, Inc.
Gastroenterology & Urology · 59d
Cleared May 27, 1983
RECTAL TUBES
K830986 · KNT
Medovations, Inc.
Gastroenterology & Urology · 59d
Cleared May 27, 1983
LEVIN TUBE
K830987 · KNT
Medovations, Inc.
Gastroenterology & Urology · 59d
Cleared May 27, 1983
REDOX CONTROLLER
K830994 · KDN
St. Louis Univ. Medical Center
Gastroenterology & Urology · 59d