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
82729–82752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2000
QUART ARTERIAL FILTER, MODEL HBF 140
K001787 · DTM
Jostra Medizintechnik AG
Cardiovascular · 17d
Cleared Jun 30, 2000
STEATHSTATION TREATMENT GUIDANCE PLATFORM
K001801 · HAW
Medtronic Surgical Navigation
Neurology · 16d
Cleared Jun 30, 2000
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K001834 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 14d
Cleared Jun 30, 2000
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K001862 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 11d
Cleared Jun 30, 2000
UNICORN MODEL SYS0630
K001888 · KPS
Danish Diagnostic Development A/S
Radiology · 15d
Cleared Jun 30, 2000
RECTOSIGHT RS 300-04
K994130 · FER
Sightline Technologies , Ltd.
Gastroenterology & Urology · 206d
Cleared Jun 29, 2000
URANUS, COMFORTOUCH LASER SYSTEM
K001031 · GEX
Laser Max Medical Technologies Corp.
General & Plastic Surgery · 91d
Cleared Jun 29, 2000
SPINE SYSTEM EVOLUTION
K001080 · KWP
Aesculap, Inc.
Orthopedic · 86d
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