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
75025–75048 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2002
STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM...
K022033 · JEY
Bioplate, Inc.
Dental · 28d
Cleared Jul 19, 2002
MODIFICATION TO RAICHEM CALCIUM REAGENT
K022049 · CJY
Hemagen Diagnostics, Inc.
Chemistry · 25d
Cleared Jul 18, 2002
REPROCESSED FEMORAL COMPRESSION DEVICE
K012574 · NMF
Sterilmed, Inc.
Cardiovascular · 343d
Cleared Jul 18, 2002
QIZHOU ACUPUNCTURE NEEDLE
K013926 · MQX
Wujiang City Shenli Medical and...
General Hospital · 232d
Cleared Jul 18, 2002
STEAMPLUS STERILIZATION TEST
K020409 · JOJ
Spsmedical Supply Corp.
General Hospital · 161d
Cleared Jul 18, 2002
MICOMED POSTERIOR DOUBLEROD SYSTEM
K021275 · MNI
Micomed Ortho GmbH
Orthopedic · 87d
Cleared Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
K021326 · CDZ
bioMerieux, Inc.
Chemistry · 83d
Cleared Jul 18, 2002
V-2100G ADVANCED INFANT INCUBATOR
K021809 · FMZ
Atom Medical Corp
General Hospital · 45d
Cleared Jul 18, 2002
GALT MEDICAL GUIDEWIRE
K021990 · DQX
Galt Medical Corp.
Cardiovascular · 30d
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