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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37993–38016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2014
VADO STEERABLE SHEATH
K140420 · DYB
Kalila Medical, Inc.
Cardiovascular · 42d
Cleared Apr 01, 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION...
K140541 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 31, 2014
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
K131848 · FRO
Puricore, Inc.
General & Plastic Surgery · 283d
Cleared Mar 31, 2014
SYNTHES SYNSONIC ULNA NAIL
K131984 · HSB
Synthes (Usa)
Orthopedic · 276d
Cleared Mar 31, 2014
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST...
K132850 · GXQ
Rti Surgical, Inc.
Neurology · 201d
Cleared Mar 31, 2014
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL...
K133721 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 116d
Cleared Mar 31, 2014
MIROMATRIX BIOLOGICAL MESH
K134033 · FTM
Miromatrix Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 31, 2014
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
K134044 · DQK
Cardio Tek, BV
Cardiovascular · 90d
Cleared Mar 31, 2014
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE...
K140505 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 32d
Cleared Mar 31, 2014
ICEROD CX CRYOABLATION NEEDLE
K140584 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 24d
Cleared Mar 28, 2014
AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
K122298 · IZL
Ajex Meditech., Ltd.
Radiology · 605d
Cleared Mar 28, 2014
STERRAD 50/100S/200 TEST PACK
K130263 · FRC
Advanced Sterilization Products
General Hospital · 417d
Cleared Mar 28, 2014
X-RAY TV SYSTEM SONIAL VISION G4
K131075 · JAA
Shimadzu Corp.
Radiology · 345d
Cleared Mar 28, 2014
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
K131861 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 277d
Cleared Mar 28, 2014
I-HIP TOTAL HIP SYSTEM
K132572 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 225d
Cleared Mar 28, 2014
VITAL COUGH
K132988 · NHJ
Lung Assist, Inc.
Anesthesiology · 185d
Cleared Mar 28, 2014
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL...
K133116 · KCT
Conmed Corporation
General Hospital · 179d
Cleared Mar 28, 2014
QUICK JET M
K133170 · EFB
Micron Corp.
Dental · 162d
Cleared Mar 28, 2014
ORTHOSCAN FD MINI C-ARM
K133174 · OXO
Orthoscan, Inc.
Radiology · 162d
Cleared Mar 28, 2014
B&B BUBBLER
K133210 · BYE
S & T Medical Technologies, Inc.
Anesthesiology · 162d
Cleared Mar 28, 2014
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C...
K133344 · LCP
Sebia
Chemistry · 149d
Cleared Mar 28, 2014
NEUROSTAR TMS THERAPY SYSTEM
K133408 · OBP
Neuronetics
Neurology · 142d
Cleared Mar 28, 2014
PEEK FUSION IMPLANT
K133515 · HWC
Mtp Solutions, LLC
Orthopedic · 133d
Cleared Mar 28, 2014
FLOCAP
K133540 · CCK
Maxtec, Inc.
Anesthesiology · 130d