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
48985–49008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2010
PENRITH ELETTRA ULTRASOUND SYSTEM
K100598 · IYN
Penrith Corporation
Radiology · 261d
Cleared Nov 19, 2010
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH...
K101822 · LZC
Sgmp Co., Ltd.
General Hospital · 142d
Cleared Nov 19, 2010
EQUASHIELD SYSTEM PROTECTIVE PLUS
K101940 · LHI
Equashield Medical , Ltd.
General Hospital · 130d
Cleared Nov 19, 2010
VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET
K102010 · FMI
Medpro Safety Products, Inc.
General Hospital · 126d
Cleared Nov 19, 2010
OSTEON, OSTEON SINUS, OSTEON LIFTING
K102015 · LYC
Genoss Co., Ltd.
Dental · 126d
Cleared Nov 19, 2010
CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
K102147 · DWC
Cardioquip Llp
Cardiovascular · 112d
Cleared Nov 19, 2010
NANOCERAM- BRIGHT
K102257 · EBF
Dmp, Ltd.
Dental · 101d
Cleared Nov 19, 2010
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K102390 · IYN
Sonosite,Inc.
Radiology · 88d
Cleared Nov 19, 2010
VOCO IONOFIL MOLAR AC QUICK
K102612 · EMA
Voco GmbH
Dental · 70d
Cleared Nov 19, 2010
UNIVERSAL IRRIGATION SOLUTION HYBRID
K102855 · OCX
Byrne Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Nov 19, 2010
BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE....
K102880 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 50d
Cleared Nov 19, 2010
BARRIER N95 PARTICULATE RESPIRATOR
K102923 · MSH
Molnlycke Health Care
General Hospital · 49d
Cleared Nov 19, 2010
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
K103057 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 35d
Cleared Nov 19, 2010
SPECTRA OPTIA R APHERESIS SYSTEM
K103090 · LKN
Caridianbct, Inc..
Gastroenterology & Urology · 31d
Cleared Nov 19, 2010
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
K103118 · GEX
Hoya Photonics, Inc.
General & Plastic Surgery · 29d
Cleared Nov 19, 2010
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
K103124 · LPH
Stryker Corporation
Orthopedic · 28d
Cleared Nov 18, 2010
RANDOX METHADONE ASSAY
K092272 · DJR
Randox Laboratories, Ltd.
Toxicology · 478d
Cleared Nov 18, 2010
AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
K093891 · JAK
Toshibamedical Systems Corporation
Radiology · 335d
Cleared Nov 18, 2010
I-ROOT
K100450 · LQY
S-Denti Co., Ltd.
Dental · 274d
Cleared Nov 18, 2010
COULTER 4C-EX 300 CELL CONTROL
K100607 · JPK
Beckman Coulter, Inc.
Hematology · 260d
Cleared Nov 18, 2010
K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
K100720 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 248d
Cleared Nov 18, 2010
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
K101031 · DQA
Masimo Corporation
Anesthesiology · 219d
Cleared Nov 18, 2010
SENSOMETRICS SOFTWARE
K101133 · GWM
Dpcom AS
Neurology · 210d
Cleared Nov 18, 2010
SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
K101244 · FLL
Truer Medical, Inc.
General Hospital · 198d