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
76009–76032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2002
OBC-127 BREAST ARRAY COIL
K021575 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Jun 12, 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715 · LOD
Exactech, Inc.
Orthopedic · 20d
Cleared Jun 12, 2002
APEX MEDICAL DIGITAL TENS TS1211, TS1212
K021755 · GZJ
Apex Medical Corp.
Neurology · 14d
Cleared Jun 11, 2002
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
K012512 · NCX
Radiant Medical
Neurology · 309d
Cleared Jun 11, 2002
PLEXOLONG SETS
K013041 · CAZ
Pajunk GmbH
Anesthesiology · 274d
Cleared Jun 11, 2002
BIOSCREW XTRALOK
K013131 · HWC
Linvatec Corp.
Orthopedic · 265d
Cleared Jun 11, 2002
CALCIGEN-S BONE VOID FILER
K013790 · MQV
Biomet Orthopedics, Inc.
Orthopedic · 209d
Cleared Jun 11, 2002
OXYARM CO2
K014211 · CCK
Southmedic, Inc.
Anesthesiology · 172d
Cleared Jun 11, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64...
K020410 · LON
Dade Behring, Inc.
Microbiology · 124d
Cleared Jun 11, 2002
RABEA CEMENT RESTRICTOR
K020836 · JDK
Signus Medical, LLC
Orthopedic · 89d
Cleared Jun 11, 2002
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
K020866 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 85d
Cleared Jun 11, 2002
FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
K020869 · DKZ
Worldwide Medical Corp.
Toxicology · 85d
Cleared Jun 11, 2002
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
K021018 · JWY
Dade Microscan, Inc.
Microbiology · 74d
Cleared Jun 11, 2002
COULTER CELLPREP
K021150 · GKH
Beckman Coulter, Inc.
Hematology · 62d
Cleared Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · NBW
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Jun 11, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH...
K021561 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 29d
Cleared Jun 11, 2002
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K021667 · LYZ
Safehealth Medical Supply Corp.
General Hospital · 21d
Cleared Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · LZO
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jun 10, 2002
SURGISIS GUIDED TISSUE REGENERATION MATRIX
K010952 · NPL
Cook Biotech, Inc.
Dental · 437d
Cleared Jun 10, 2002
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA,...
K014066 · LDJ
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK...
K014067 · DIO
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
K014069 · DIO
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297 · CHL
Nova Biomedical Corp.
Chemistry · 133d
Cleared Jun 10, 2002
OPTAX SYSTEM
K020800 · LQD
Optax Systems, Inc.
Neurology · 90d