FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74521–74544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2002
MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
K021991 · KNT
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 18, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K022015 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jul 18, 2002
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
K022165 · FTC
Theralight, Inc.
General & Plastic Surgery · 15d
Cleared Jul 17, 2002
HLS NOETOS SYSTEM
K013906 · JWH
Tornier
Orthopedic · 233d
Cleared Jul 17, 2002
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020413 · LON
Dade Behring, Inc.
Microbiology · 160d
Cleared Jul 17, 2002
BAYER RAPIDPOINT 405 SYSTEM
K020616 · GKR
Bayer Diagnostics Corp.
Hematology · 142d
Cleared Jul 17, 2002
SURGERY AND ACCESSORIES
K021236 · LLZ
Camtronics, Ltd.
Radiology · 90d
Cleared Jul 17, 2002
LACTOSORB MINI INTERFERENCE SCREW
K021254 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Jul 17, 2002
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K021280 · HWC
Inion , Ltd.
Orthopedic · 86d
Cleared Jul 17, 2002
WRIST FUSION PLATE
K021321 · HRS
Acu Med, Inc.
Orthopedic · 83d
Cleared Jul 17, 2002
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
K021383 · EFW
Agion Technologies, LLC
Dental · 76d
Cleared Jul 17, 2002
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
K021526 · LFG
ACON Laboratories, Inc.
Chemistry · 68d
Cleared Jul 17, 2002
ALBUMIN REAGENT
K021636 · CJW
Intersect Systems, Inc.
Chemistry · 61d
Cleared Jul 17, 2002
PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
K021778 · DQA
Philips Medical Systems
Anesthesiology · 48d
Cleared Jul 17, 2002
DIGITAL CLINICAL THERMOMETER, MODEL KD-193
K021851 · FLL
K-Jump Health Co., Ltd.
General Hospital · 42d
Cleared Jul 17, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967 · MQP
Implex Corp.
Orthopedic · 30d
Cleared Jul 16, 2002
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
K012018 · GEI
Acmi Corporation
General & Plastic Surgery · 383d
Cleared Jul 16, 2002
DEVILBISS SLEEP RECORDER MODEL # RM60
K012437 · MNR
Sunrise Medical Hhg, Inc.
Anesthesiology · 350d
Cleared Jul 16, 2002
AUTOSET SPIRIT CPAP SYSTEM
K013843 · BZD
ResMed Corp
Anesthesiology · 238d
Cleared Jul 16, 2002
AVID-NIT NERVE STIMULATION NEEDLES
K014246 · CAZ
Avid N.I.T., Inc.
Anesthesiology · 202d
Cleared Jul 16, 2002
INFANT FEEDING TUBES
K020005 · KNT
Promedic, Inc.
Gastroenterology & Urology · 195d
Cleared Jul 16, 2002
THE DIVACUP MENSTRUAL SOLUTION
K021356 · HHE
Diva International, Inc.
Obstetrics & Gynecology · 78d
Cleared Jul 16, 2002
INSEMINATION CATHETER, MODEL 320301
K021438 · MFD
Labotect Labor-Technik Gottingen
Obstetrics & Gynecology · 71d
Cleared Jul 16, 2002
ONLINE DAT II METHADONE II
K021505 · DJR
Roche Diagnostics Corp.
Toxicology · 68d