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
43729–43752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2012
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
K120377 · GEX
J. Morita USA, Inc.
General & Plastic Surgery · 170d
Cleared Jul 25, 2012
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
K120625 · MXJ
Roche Diagnostics
Microbiology · 146d
Cleared Jul 25, 2012
FLEXITIME FAST & SCAN LIGHT FLOW
K120914 · ELW
Heraeus Kulzer, LLC
Dental · 120d
Cleared Jul 25, 2012
POSISEP AND POSISEP X HEMOSTAT DRESSINGS
K120958 · QSY
Hemostasis, LLC
General & Plastic Surgery · 117d
Cleared Jul 25, 2012
DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA,...
K120988 · DWF
Medtronic, Inc.
Cardiovascular · 114d
Cleared Jul 25, 2012
TL TRISEB CREAM
K121134 · FRO
Trigen Laboratories, Inc.
General & Plastic Surgery · 103d
Cleared Jul 25, 2012
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
K121195 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 97d
Cleared Jul 25, 2012
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
K121252 · KTT
Stryker Corp.
Orthopedic · 91d
Cleared Jul 25, 2012
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
K121275 · FRO
Convatec, Inc.
General & Plastic Surgery · 89d
Cleared Jul 25, 2012
IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
K121510 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 65d
Cleared Jul 25, 2012
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
K121557 · LDJ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 61d
Cleared Jul 25, 2012
CLEARFIL MAJESTY FLOW
K121583 · EBF
Kuraray Noritake Dental, Inc.
Dental · 56d
Cleared Jul 25, 2012
SYNTHES ZERO-P VARIABLE ANGLE (VA)
K121852 · OVE
Synthes Spine Co.Lp
Orthopedic · 30d
Cleared Jul 25, 2012
SAFETY INFUSION SET
K121908 · FMI
Greiner Bio-One North America, Inc.
General Hospital · 26d
Cleared Jul 24, 2012
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3...
K113546 · MRG
Roche Diagnostics
Chemistry · 236d
Cleared Jul 24, 2012
O2PAK OXYGEN GENERATOR
K120566 · CAW
Pacific Precision Products
Anesthesiology · 148d
Cleared Jul 24, 2012
MICROLUX/DL MICROLUX/BLU BIO/SCREEN
K121282 · NXV
Addent, Inc.
Dental · 85d
Cleared Jul 24, 2012
COMPRESSION CARE FLIGHT
K121376 · JOW
Medical Minds, LLC
Cardiovascular · 77d
Cleared Jul 24, 2012
CONE-TROL LIQUID CHEMISTRY CONTROLS
K121759 · JJY
Cone Bioproducts
Chemistry · 39d
Cleared Jul 24, 2012
E1 EAR SENSORS
K121912 · DQA
Masimo Corporation
Anesthesiology · 22d
Cleared Jul 23, 2012
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL...
K121229 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 90d
Cleared Jul 23, 2012
NIO 5MP
K121788 · LLZ
Barco N.V.
Radiology · 35d
Cleared Jul 23, 2012
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE...
K121907 · CJO
Siemens Healthcare Diagnostics
Chemistry · 24d
Cleared Jul 20, 2012
SURGICASE CONNECT, SURGICASE GUIDE
K112389 · PBF
Materialise NV
Orthopedic · 337d