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
82393–82416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2000
ETEST ESBL CT/CTL STRIP
K001547 · JWY
Ab Biodisk
Microbiology · 81d
Cleared Aug 07, 2000
STATLYTE NA/K/CL/LI ANALYZER
K001761 · JGS
Nova Biomedical Corp.
Chemistry · 59d
Cleared Aug 07, 2000
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
K001767 · LJO
Diamedix Corp.
Microbiology · 56d
Cleared Aug 07, 2000
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K002134 · CGA
Selfcare, Inc.
Chemistry · 24d
Cleared Aug 07, 2000
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
K002196 · JJY
Bio-Rad
Chemistry · 18d
Cleared Aug 07, 2000
LACTOSORB PANELS AND FASTENERS
K984390 · HRS
Biomet, Inc.
Orthopedic · 608d
Cleared Aug 07, 2000
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
K994395 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 223d
Cleared Aug 04, 2000
ENRAF-NONIUS SONOPULS 190 SYSTEM
K000084 · IMI
Henley Healthcare, Inc.
Physical Medicine · 205d
Cleared Aug 04, 2000
HDL CHOLESTEROL PLUS
K000568 · LBT
Roche Diagnostics Corp.
Chemistry · 164d
Cleared Aug 04, 2000
SONIC, MODEL SO-100
K000593 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 164d
Cleared Aug 04, 2000
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001,...
K000653 · MRN
Pulmonox Medical Corp.
Anesthesiology · 158d
Cleared Aug 04, 2000
APEX MODULAR HIP STEM
K000788 · LPH
Apex Surgical, LLC
Orthopedic · 147d
Cleared Aug 04, 2000
RANDOX C-REACTIVE PROTEIN
K001009 · DCK
Randox Laboratories, Ltd.
Immunology · 128d
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS-HA
K001448 · MEH
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS
K001449 · LZO
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Aug 04, 2000
E-Z LINK CROSS CONNECTOR
K001470 · KWP
Depuyacromed
Orthopedic · 85d
Cleared Aug 04, 2000
TORQUE INSTRUMENT, MODEL 8500
K001476 · LXM
Spinalight, Inc.
Physical Medicine · 85d
Cleared Aug 04, 2000
BAUMER FEMORAL HEAD
K001571 · JDI
Baumer, S.A
Orthopedic · 74d
Cleared Aug 04, 2000
STRYKER TRAUMA PELVIC SET
K001614 · KTW
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Aug 04, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K001645 · GKP
Dade Behring, Inc.
Hematology · 66d
Cleared Aug 04, 2000
PASCO MIC AND MIC/ID PANELS
K001721 · LTT
Pasco Laboratories, Inc.
Microbiology · 59d
Cleared Aug 04, 2000
STIMULAN -CALCIUM SULFATE BONE VOID FILTER
K001724 · MQV
Biocomposites, Ltd.
Orthopedic · 59d
Cleared Aug 04, 2000
ACCELERATOR RECIPROCATING CANNULA
K001803 · QPB
Byron Medical
General & Plastic Surgery · 51d
Cleared Aug 04, 2000
DORO HEADREST SYSTEM
K001808 · HBL
Pro-Med Instruments GmbH
Neurology · 50d