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

Filters: Cleared only ×
175,820 results
141985–142008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1986
DSL-4800 ACTIVE TM TSH EIA SYSTEM
K864134 · JLW
Diagnostic Systems Laboratories, Inc.
Chemistry · 56d
Cleared Dec 16, 1986
CRIS ADAPTED WITH VOLUME LIMITING BAG
K864164 · FPA
Y
General Hospital · 54d
Cleared Dec 16, 1986
STA-SET MODEL 250 I.V. FLOW REGULATOR
K864229 · LDR
Sta-Set Corp.
General Hospital · 49d
Cleared Dec 16, 1986
ROTATION AIR FLUIDIZED BED/DELTA
K864232 · IOQ
Kinetic Concepts, Inc.
Physical Medicine · 49d
Cleared Dec 16, 1986
IQ TRIGLYCERIDES
K864268 · CDT
Bd Becton Dickinson Vacutainer...
Chemistry · 48d
Cleared Dec 16, 1986
3M GLASS IONOMER LINER
K864270 · EMA
3M Company
Dental · 48d
Cleared Dec 16, 1986
WAKO(TM) GOT II - HA
K864302 · CIT
Wako Chemicals USA, Inc.
Chemistry · 46d
Cleared Dec 16, 1986
TDX(R) II ANALYZER
K864319 · JJQ
Abbott Laboratories
Chemistry · 43d
Cleared Dec 16, 1986
ELECTRIFIED TRANSFER TOILET SEAT
K864324 · ILK
Robert E. Roy
Physical Medicine · 42d
Cleared Dec 16, 1986
WAKO GPT II - HA
K864335 · CKA
Wako Chemicals USA, Inc.
Chemistry · 42d
Cleared Dec 16, 1986
SEGMENTAL SPINAL INSTRUMENTATION SYSTEM
K864337
Kirschner Medical Corp.
Orthopedic · 42d
Cleared Dec 16, 1986
IQ URIC ACID TEST
K864341 · KNK
Bd Becton Dickinson Vacutainer...
Chemistry · 42d
Cleared Dec 16, 1986
COMFORT+LIFT CHAIR
K864366 · INO
Invacare Corp.
Physical Medicine · 41d
Cleared Dec 16, 1986
LOW VOLUME EXTENSION SET
K864395 · FPK
Panamedix, Inc.
General Hospital · 40d
Cleared Dec 16, 1986
VISION(TM) AMYLASE
K864435 · JFJ
Abbott Laboratories
Chemistry · 34d
Cleared Dec 16, 1986
KOKEN'S NEW MODEL M-3000 POWER TABLE
K864501
Koken Mfg Company, Inc.
Physical Medicine · 32d
Cleared Dec 16, 1986
LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
K864529 · GDY
Elof Hansson, Inc.
General & Plastic Surgery · 29d
Cleared Dec 16, 1986
IQ T4 IMMUNOASSAY
K864560 · CDX
Bd Becton Dickinson Vacutainer...
Chemistry · 27d
Cleared Dec 16, 1986
ALT WHEELCHAIR
K864573 · IOR
Alt Design
Physical Medicine · 26d
Cleared Dec 16, 1986
ADOBE ENTERPRISES SURGICAL/BANDAGE SCISSORS FORCEP
K864608 · GEN
Adobe Ent.
General & Plastic Surgery · 22d
Cleared Dec 16, 1986
MODIFIED DUAL LUMEN NEEDLE
K864629 · LBW
Quinton, Inc.
Gastroenterology & Urology · 21d
Cleared Dec 16, 1986
ACTIVE LIGHTWEIGHT WHEELCHAIR
K864684 · IOR
A-Bec Mobility, Inc.
Physical Medicine · 14d
Cleared Dec 16, 1986
SCOOTA MOTORIZED VEHICLE
K864686 · INI
A-Bec Mobility, Inc.
Physical Medicine · 14d
Cleared Dec 16, 1986
I.V. START KITS
K864693
Salt Creek Medical Technologies
General & Plastic Surgery · 14d