FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81793–81816 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 04, 2000
CLEARFIL ST OPAQUER
K001913 · EBF
Kuraray Company, Ltd.
Dental · 42d
Cleared Aug 04, 2000
CERALAS D10 810NM LASER, MODEL CERALAS D10-60
K001975 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 36d
Cleared Aug 04, 2000
EEI SLUSH PAN DRAPE
K001994 · KKX
Eagle Endoscopic, Inc.
General Hospital · 35d
Cleared Aug 04, 2000
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL...
K002107 · MVM
Scimedx Corp.
Immunology · 23d
Cleared Aug 04, 2000
MODEL 9000 PEDIATRIC WHEELCHAIR
K002170 · IOR
Invacare Corp.
Physical Medicine · 16d
Cleared Aug 04, 2000
ALLEGIANCE GENESIS CONTAINER SYSTEM
K983299 · FRG
Allegiance Healthcare Corp.
General Hospital · 683d
Cleared Aug 04, 2000
MICROTARGETING ELECTRODE
K991522 · GZL
FHC, Inc.
Neurology · 459d
Cleared Aug 04, 2000
ARTHREX CHONDRAL DART, MODEL AR-4005B-18
K991971 · HTY
Arthrex, Inc.
Orthopedic · 420d