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
43921–43944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K121871 · MWI
Airstrip Technologies, LP
Cardiovascular · 6d
Cleared Jul 02, 2012
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL...
K113435 · KHS
Alfa Wassermann
Chemistry · 224d
Cleared Jul 02, 2012
K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER
K120285 · BZD
Curative Medical, Inc.
Anesthesiology · 153d
Cleared Jul 02, 2012
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
K121448 · MUJ
Elekta Inc. D/B/A Nucletron Corporation
Radiology · 48d
Cleared Jul 02, 2012
ASTHMAPOLIS SYSTEM
K121609 · CAF
Reciprocal Labs Corporation
Anesthesiology · 31d
Cleared Jun 29, 2012
FREEDOM(R) STEMMED TIBIAL COMPONENTS
K111785 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 371d
Cleared Jun 29, 2012
AC WOUND TREATMENT SYSTEM
K111949 · OMP
Nanovibronix, Inc.
General & Plastic Surgery · 357d
Cleared Jun 29, 2012
CLEARPATH 24
K112318 · OCX
Promedic, Inc.
Gastroenterology & Urology · 323d
Cleared Jun 29, 2012
TUBALGATOR
K113080 · HIN
Mectra Labs, Inc.
Obstetrics & Gynecology · 255d
Cleared Jun 29, 2012
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
K113200 · LON
bioMerieux, Inc.
Microbiology · 242d
Cleared Jun 29, 2012
ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA...
K113459 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 220d
Cleared Jun 29, 2012
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT...
K113512 · JEY
Biomet Microfixation
Dental · 214d
Cleared Jun 29, 2012
ARCHSTENT BILIARY SYSTEM
K113582 · FGE
Ostial Corporation
Gastroenterology & Urology · 207d
Cleared Jun 29, 2012
MOUNTED MEDICAL OXYGEN SYSTEM
K113767 · BYJ
Essex Industries, Inc.
Anesthesiology · 191d
Cleared Jun 29, 2012
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM...
K113775 · LOX
Ostial Corporation
Cardiovascular · 190d
Cleared Jun 29, 2012
ANY VIEW PATIENT MONITORS
K120193 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 158d
Cleared Jun 29, 2012
TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE...
K120218 · EFB
Palm Beach Dental Supply D/B/A Tek USA
Dental · 156d
Cleared Jun 29, 2012
ICTA
K120260 · OMB
Excel-Tech Ltd. (Xltek)
Neurology · 154d
Cleared Jun 29, 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K120459 · DYB
Oscor, Inc.
Cardiovascular · 135d
Cleared Jun 29, 2012
EXACTRAC ROBOTICS NOVALIS ROBOTICS
K120520 · JAI
Brainlab AG
Radiology · 129d
Cleared Jun 29, 2012
SC TIP CLEANER
K120581 · GEI
Nsi
General & Plastic Surgery · 123d
Cleared Jun 29, 2012
INTELLISPACE ECG
K120855 · DQK
Philips Health Care
Cardiovascular · 100d
Cleared Jun 29, 2012
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
K120897 · FTL
Sofradim Production
General & Plastic Surgery · 95d
Cleared Jun 29, 2012
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
K120963 · LYY
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 91d