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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81625–81648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 2000
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
K001679 · CIT
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Jun 28, 2000
XPLAN 2.1
K001700 · MUJ
Radionics, Inc.
Radiology · 23d
Cleared Jun 28, 2000
ELECSYS INSULIN CALCHECK
K001846 · JJX
Roche Diagnostics Corp.
Chemistry · 9d
Cleared Jun 28, 2000
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
K994419 · LTJ
Qualisys Diagnostics, Inc.
Immunology · 182d
Cleared Jun 27, 2000
MODIFICATION TO NC-STAT
K000565 · JXE
Neurometrix, Inc.
Neurology · 126d
Cleared Jun 27, 2000
SCANDINAVIAN IVF SCIENCES AB, G2.2
K000619 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 131d
Cleared Jun 27, 2000
MODIFIED SINGLE AXLE TOTAL ELBOW
K000683 · JDC
Biomet, Inc.
Orthopedic · 119d
Cleared Jun 27, 2000
LEICA COLPOSCOPE
K000707 · HEX
Leica Microscopy Systems , Ltd.
Obstetrics & Gynecology · 117d
Cleared Jun 27, 2000
ELECTROSURGICAL ELECTRODE FAMILY
K001151 · GEI
Novasys Medical, Inc.
General & Plastic Surgery · 78d
Cleared Jun 27, 2000
MONARCH II IOL DELIVERY SYSTEM
K001157 · KYB
Alcon Research, Ltd.
Ophthalmic · 78d
Cleared Jun 27, 2000
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY...
K001180 · DTE
Pace Medical
Cardiovascular · 77d
Cleared Jun 27, 2000
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
K001258 · FGE
Cordis Corp.
Gastroenterology & Urology · 70d
Cleared Jun 27, 2000
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM
K001305 · DQK
General Electric Medical Systems...
Cardiovascular · 64d
Cleared Jun 27, 2000
AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K001382 · GEI
Aaron Medical Industries
General & Plastic Surgery · 56d
Cleared Jun 27, 2000
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
K001517 · IZL
Shimadzu Corp.
Radiology · 42d
Cleared Jun 26, 2000
MACROPOREDX DISTRACTOR SYSTEM
K000992 · MQN
Macropore Biosurgery, Inc.
Dental · 90d
Cleared Jun 26, 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · HRX
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Jun 26, 2000
ADVIA IMS
K001344 · DIH
Bayer Corp.
Chemistry · 60d
Cleared Jun 26, 2000
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · JFJ
Sigma Diagnostics, Inc.
Chemistry · 38d
Cleared Jun 23, 2000
VIVANT MEDICAL BIOPSY MARKER SYSTEM
K000278 · FZP
Vivant Medical, Inc.
General & Plastic Surgery · 144d
Cleared Jun 23, 2000
HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE
K000351 · LYY
Hanwella Rubber Products , Ltd.
General Hospital · 140d
Cleared Jun 23, 2000
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
K000827 · KRR
Walter Abendschein, M.D.
Orthopedic · 101d
Cleared Jun 23, 2000
KLINIDRAPE SURGICAL DRAPES
K000906 · KKX
Molnlycke Health Care, Inc.
General Hospital · 94d
Cleared Jun 23, 2000
OPUS 10 DENTAL DIODE LASER
K000990 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 87d