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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143833–143856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1986
ARISE, VIVRE DEBOUT
K862305 · IPL
Natco Corp.
Physical Medicine · 22d
Cleared Jul 09, 1986
TANNING SOFA
K862341 · FTC
Hardwood Design Shop
General & Plastic Surgery · 19d
Cleared Jul 09, 1986
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)
K862353 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 19d
Cleared Jul 09, 1986
ULTRATAN TANNING SYSTEM
K862372 · FTC
Health Systems Intl., Inc.
General & Plastic Surgery · 15d
Cleared Jul 09, 1986
THE RELAXARE EXERCISE AND MASSAGE UNIT
K862411 · JFB
Relaxare Corp.
Physical Medicine · 14d
Cleared Jul 08, 1986
ORTHOBLEND POWERED BONE MILL
K860356 · LYS
Zimmer, Inc.
Orthopedic · 159d
Cleared Jul 08, 1986
ADCOMP
K860610 · LHI
Healthtek, Inc.
General Hospital · 139d
Cleared Jul 08, 1986
CW DOPPLER STATIC TRANSDUCERS
K861109 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 105d
Cleared Jul 08, 1986
GHI WET PENCIL
K861614 · GEI
Surgical Products Corp.
General & Plastic Surgery · 70d
Cleared Jul 08, 1986
MEDSURG CUSTOM DRESSING TRAYS
K861693
Medsurg Industries, Inc.
General & Plastic Surgery · 67d
Cleared Jul 08, 1986
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM
K861766 · JDW
Howmedica Corp.
Orthopedic · 62d
Cleared Jul 08, 1986
STANDING WHEELER
K862013 · IPL
Engineering Mechanics, Co.
Physical Medicine · 41d
Cleared Jul 08, 1986
ARMBOARDS, REUSABLE AND DISPOSABLE
K862111
Abco Dealers, Inc.
General & Plastic Surgery · 35d
Cleared Jul 08, 1986
KING DIAGNOSTICS URIC ACID TEST
K862208 · KNK
King Diagnostics, Inc.
Chemistry · 28d
Cleared Jul 08, 1986
T.P.N. DRESSING CHANGE TRAY
K862219
Welmed Systems, Inc.
General & Plastic Surgery · 27d
Cleared Jul 08, 1986
WARSAW ORTHOPEDIC BONE PLATE
K862254 · HRS
Warsaw Orthopedic, Inc.
Orthopedic · 25d
Cleared Jul 08, 1986
KOTEX LIGHTDAYS DEODORANT PANTILINERS
K862285 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 22d
Cleared Jul 08, 1986
(MT-27) THERMOMETER AND (M-10PC) PROBE COVERS
K862333 · FLL
Sharp Electronics Corp.
General Hospital · 19d
Cleared Jul 08, 1986
CATALOG NO. I/A 100 AND KPE 200
K862334
Ipax, Inc.
General & Plastic Surgery · 28d
Cleared Jul 08, 1986
PRO-CLEAN
K862367
Dermacare Products, Inc.
General & Plastic Surgery · 14d
Cleared Jul 07, 1986
5.0 MHZ INTRAOPERATIVE ARRAY
K860123 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 174d
Cleared Jul 07, 1986
MODEL 545-45 LASER FOR DERMA., POD., SURGICAL
K860974 · GEX
Britt Corp., Inc.
General & Plastic Surgery · 115d
Cleared Jul 07, 1986
DIRECT ACU-SLIDE TEST
K861212 · JHJ
Cal-Tech Diagnostics, Inc.
Chemistry · 98d
Cleared Jul 07, 1986
ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST
K861378 · JOP
Ultramed, Inc.
Cardiovascular · 84d