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
143041–143064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1986
COLLIMATOR MODEL A280BLE & MODEL A280-BLM
K861942 · IZW
D&R X-Ray Products, Inc.
Radiology · 66d
Cleared Jul 25, 1986
EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM
K862279 · KTW
Orthospec, Inc.
Orthopedic · 39d
Cleared Jul 25, 1986
SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN
K862311 · KTT
Warsaw Orthopedic, Inc.
Orthopedic · 38d
Cleared Jul 25, 1986
STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS
K862482 · JEY
Walter Lorenz Surgical, Inc.
Dental · 25d
Cleared Jul 24, 1986
ULTRASOUND IMAGING SYSTEM MODEL 280 SL
K860697 · IYO
Johnson & Johnson Professionals, Inc.
Radiology · 149d
Cleared Jul 24, 1986
HOWMEDICA KINEMATIC PLUS KNEE SYSTEM
K861266 · JWH
Howmedica Corp.
Orthopedic · 111d
Cleared Jul 24, 1986
INTELLIGRAPH(TM) PROGRAMMER
K861598 · FRN
Intelligent Medicine, Inc.
General Hospital · 86d
Cleared Jul 24, 1986
MERIDIAN IMAGING SYSTEM
K861737 · JOP
Johnson & Johnson Professionals, Inc.
Cardiovascular · 79d
Cleared Jul 24, 1986
ACUSON S319 TRANSDUCER
K862159 · JOP
Acuson Computed Sonography
Cardiovascular · 48d
Cleared Jul 24, 1986
MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT
K862335
U.S. Mfg. & Management, Inc.
General & Plastic Surgery · 35d
Cleared Jul 24, 1986
DANNIFLEX 400SL
K862730 · BXB
Danninger Medical Technology, Inc.
Physical Medicine · 6d
Cleared Jul 23, 1986
CLINAGEL (ABSORBENT GEL)
K860892 · FRO
Schering Chemicals, C/O Ellis...
General & Plastic Surgery · 135d
Cleared Jul 23, 1986
HYGIENIC AIR PURIFYING DEVICE
K861299 · FRF
Puridyne, Inc./Imutech, Inc.
General Hospital · 107d
Cleared Jul 23, 1986
ELECTRO-SURGICAL PENCILS
K861742 · GEI
Stryker Corp.
General & Plastic Surgery · 78d
Cleared Jul 23, 1986
NIDEK KM-1000 SURGICAL KERATOMETER
K862137 · HLQ
Nidek, Inc.
Ophthalmic · 49d
Cleared Jul 23, 1986
MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER
K862203 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 43d
Cleared Jul 23, 1986
NEMECTROSON MODEL 2
K862376 · IMJ
Nemectron Medical, Inc.
Physical Medicine · 29d
Cleared Jul 23, 1986
REFLEX(TM) CLIP APPLIER
K862404 · FZP
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 28d
Cleared Jul 23, 1986
CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE
K862481 · GDM
CIVCO Medical Instruments Co., Inc.
General & Plastic Surgery · 23d
Cleared Jul 23, 1986
CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000
K862509 · JDY
Lifestream Int'L, Inc.
Orthopedic · 22d
Cleared Jul 23, 1986
BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR
K862519 · HOS
Bausch & Lomb, Inc.
Ophthalmic · 22d
Cleared Jul 23, 1986
LINEN (HUCK) TOWEL
K862577 · KKX
Dimed, Intl.
General Hospital · 16d
Cleared Jul 23, 1986
TECHNA VISION CASTING RESIN
K862578 · HQG
Techna Vision
Ophthalmic · 16d
Cleared Jul 23, 1986
VARIOUS SURGICAL INSTRUMENTS
K862597 · GAD
Konig W.G., Ltd.
General & Plastic Surgery · 21d