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
31369–31392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2016
Halo One Thin-Walled Guiding Sheath
K161183 · DYB
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared Jun 02, 2016
ABC D-FLEX PROBE
K151229 · GEI
Conmed Corporation
General & Plastic Surgery · 392d
Cleared Jun 02, 2016
MTR550 (Tentative) Antimicrobial Silver Wound Gel
K152519 · FRO
Medical Technology Research, Inc.
General & Plastic Surgery · 273d
Cleared Jun 02, 2016
Anker II Dental Implant System
K152576 · DZE
Alliance Global Technology Co., Ltd.
Dental · 267d
Cleared Jun 02, 2016
Helios III
K152856 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 247d
Cleared Jun 02, 2016
Gun Oil, Pink, Gun Oil H2O, Pink Water
K152918 · NUC
Empowered Products, Inc.
Obstetrics & Gynecology · 244d
Cleared Jun 02, 2016
NobelDesign Software
K153036 · NHA
Nobel Biocare AB
Dental · 227d
Cleared Jun 02, 2016
PowerGlide Pro Midline Catheter
K153280 · FOZ
C.R. Bard, Inc.
General Hospital · 203d
Cleared Jun 02, 2016
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head,...
K153606 · GCJ
Smith & Nephew
General & Plastic Surgery · 168d
Cleared Jun 02, 2016
O-pel Laser and families of probe delivery devices
K160012 · GEX
Precise Light Surgical
General & Plastic Surgery · 150d
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