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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
31969–31992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2016
CEREC SpeedGlaze
K160099 · EIH
Sirona Dental Systems GmbH
Dental · 135d
Cleared Jun 02, 2016
NobelSpeedy Groovy
K160119 · DZE
Nobel Biocare AB
Dental · 135d
Cleared Jun 02, 2016
VARIOunite
K160244 · NHA
Thommen Medical AG
Dental · 122d
Cleared Jun 02, 2016
16ch Tx/Rx Knee SPEEDER
K161193 · MOS
Quality Electrodynamics, LLC
Radiology · 36d
Cleared Jun 01, 2016
DCI Edge Dental Chair with Operative Unit
K151987 · KLC
Dci
Dental · 320d
Cleared Jun 01, 2016
Gemini Bonded Sterilization Wrap
K152458 · FRG
Medline Industries, Inc.
General Hospital · 278d
Cleared Jun 01, 2016
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70...
K152635 · LLL
Inova Diagnostics, Inc.
Immunology · 260d
Cleared Jun 01, 2016
Hermes Medical Imaging Suite v5.6
K153056 · KPS
Hermes Medical Solutions AB
Radiology · 224d
Cleared Jun 01, 2016
NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit,...
K153165 · PIG
Astute Medical, Inc.
Chemistry · 212d
Cleared Jun 01, 2016
Voyant Open Fusion Device
K153288 · GEI
Applied Medical Resources
General & Plastic Surgery · 201d
Cleared Jun 01, 2016
AGE Automatic Upper Arm Blood Pressure Monitor
K153552 · DXN
Ageless Health Industrial Co., Ltd.
Cardiovascular · 173d
Cleared Jun 01, 2016
Additive Orthopaedics Hammertoe Correction System
K160264 · HTY
Additive Orthopaedics, LLC
Orthopedic · 120d
Cleared Jun 01, 2016
VERIFY VH2O2 Indicator Tape
K160485 · JOJ
STERIS Corporation
General Hospital · 100d
Cleared Jun 01, 2016
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System,...
K160552 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 93d
Cleared Jun 01, 2016
FirstSense Breast Exam
K160573 · LHQ
First Sense Medical, LLC
Radiology · 93d
Cleared Jun 01, 2016
Hospira Administration Sets
K160870 · FPA
Hospira, Inc.
General Hospital · 63d
Cleared May 31, 2016
CT/MR Compatible M.A.C. Interstitial GYN Template
K150979 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 414d
Cleared May 31, 2016
NAR Sharps Shuttle
K152340 · MMK
North American Rescue, LLC
General Hospital · 286d
Cleared May 31, 2016
KARL STORZ Endoscopic ICG Imaging System
K152583 · OWN
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 264d
Cleared May 31, 2016
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non...
K160623 · GAP
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 88d
Cleared May 31, 2016
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
K160647 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 85d
Cleared May 31, 2016
CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners,...
K160900 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 60d
Cleared May 31, 2016
Cirona 6400
K161209 · JOW
Devon Medical Products
Cardiovascular · 33d
Cleared May 31, 2016
Ez3D-i / E3
K161246 · LLZ
Ewoosoft Co., Ltd.
Radiology · 28d