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
75697–75720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2002
PRIMECHAIR
K021199 · ITI
Dalton Medical Corp.
Physical Medicine · 87d
Cleared Jul 12, 2002
ENDOCERVICAL BLOCK NEEDLE
K021224 · HEE
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 12, 2002
ATAC PAK BUN REAGENT
K021385 · CDQ
Elan Diagnostics
Chemistry · 71d
Cleared Jul 12, 2002
TOPCUT
K021525 · FCG
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 63d
Cleared Jul 12, 2002
HEMOSORB
K021581 · QSY
On Site Gas Systems, Inc.
General & Plastic Surgery · 59d
Cleared Jul 12, 2002
QAB2A IGM ELISA KIT HRP
K021610 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 12, 2002
QAB2A IGG ELISA KIT HRP
K021611 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 12, 2002
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
K021624 · JJX
Bionostics, Inc.
Chemistry · 57d
Cleared Jul 12, 2002
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676 · HIB
Cypress Medical Products, Ltd.
Obstetrics & Gynecology · 52d
Cleared Jul 12, 2002
HEMADERM COTAINING HEMADEX CLOTTING BEADS
K021678 · QSY
Medafor, Inc.
General & Plastic Surgery · 52d
Cleared Jul 12, 2002
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
K021697 · JJX
Bionostics, Inc.
Chemistry · 51d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874 · DXG
Abbott Laboratories
Cardiovascular · 35d
Cleared Jul 12, 2002
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
K021927 · LXG
Biomet, Inc.
Hematology · 30d
Cleared Jul 12, 2002
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND...
K021970 · LPH
Implex Corp.
Orthopedic · 25d
Cleared Jul 12, 2002
HORIZONS CYTOLOGY BRUSH
K021998 · FDX
Horizons Intl. Corp.
Gastroenterology & Urology · 23d
Cleared Jul 12, 2002
MPOWER, MODEL 712 SERIES
K022001 · KPS
Positron Corp.
Radiology · 23d
Cleared Jul 12, 2002
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
K022053 · JHO
Sebia
Chemistry · 18d
Cleared Jul 12, 2002
EIZO, MODEL FC-2091
K022109 · LLZ
Eizo Nanao Corporation
Radiology · 14d
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · JEC
Smith & Nephew, Inc.
Orthopedic · 364d
Cleared Jul 11, 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
K013873 · GEI
Boston Scientific Corp
General & Plastic Surgery · 232d
Cleared Jul 11, 2002
LUTZ NEEDLE
K013892 · BSP
Ballard Medical Products
Anesthesiology · 230d
Cleared Jul 11, 2002
NEUROTECH MEDISTIM PLUS, TYPE 291
K014019 · IPF
Bio-Medical Research, Ltd.
Physical Medicine · 217d
Cleared Jul 11, 2002
NT MEDITENS PLUS, TYPE 290
K014020 · GZJ
Bio-Medical Research, Ltd.
Neurology · 217d
Cleared Jul 11, 2002
FT101 FOREHEAD THERMOMETER
K020433 · FLL
Idt Technology Limited
General Hospital · 153d