FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82129–82152 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2000
ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL...
K001150 · GEI
Novasys Medical, Inc.
General & Plastic Surgery · 80d
Cleared Jun 29, 2000
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC)...
K001227 · LPL
Opti-Centre Laboratories
Ophthalmic · 73d
Cleared Jun 29, 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417 · DKZ
Roche Diagnostics Corp.
Toxicology · 55d
Cleared Jun 29, 2000
SUGAR CHEX ONE
K001443 · JJX
Streck Laboratories, Inc.
Chemistry · 52d
Cleared Jun 29, 2000
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL,...
K001705 · GYB
Chester Labs, Inc.
Neurology · 24d
Cleared Jun 29, 2000
CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER
K992757 · GEX
Cynosure, Inc.
General & Plastic Surgery · 318d
Cleared Jun 29, 2000
LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM
K993154 · GEX
A.R.C. Laser Corp.
General & Plastic Surgery · 282d
Cleared Jun 29, 2000
NICOLET EME LEGEND TC22
K993939 · IYN
Nicolet Biomedical
Radiology · 223d
Cleared Jun 28, 2000
BD DIRECTIGEN FLU A+B
K001364 · PSZ
Bd Becton Dickinson Vacutainer...
Microbiology · 58d
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