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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
58201–58224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2007
GENTIAN CYSTATIN C IMMUNOASSAY
K071388 · NDY
Gentian AS
Chemistry · 172d
Cleared Nov 06, 2007
SMARTBLOCK PAIN PUMP
K072053 · MEB
Medical Flow Systems, Ltd.
General Hospital · 103d
Cleared Nov 06, 2007
ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE
K072430 · MKJ
ZOLL Medical Corporation
Cardiovascular · 69d
Cleared Nov 06, 2007
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH...
K072576 · FPA
Baxter Healthcare Corp
General Hospital · 54d
Cleared Nov 06, 2007
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K072894 · FPA
Terumo Europe N.V.
General Hospital · 26d
Cleared Nov 06, 2007
GS FIXTURE SYSTEM
K072896 · DZE
Osstem Implant Co., Ltd.
Dental · 26d
Cleared Nov 06, 2007
MEDSTREAMING MEDICAL OFFICE SOFTWARE
K072972 · LLZ
Medstreaming, LLC
Radiology · 15d
Cleared Nov 06, 2007
MULTI-SPECT
K073021 · KPS
Eagle Heart Imaging, LLC
Radiology · 11d
Cleared Nov 05, 2007
NEXT GENERATION LASER
K062624 · HQF
Alcon Laboratories
Ophthalmic · 426d
Cleared Nov 05, 2007
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
K070270 · HLJ
Kirchner & Wilhelm GmbH + Co.Kg
Ophthalmic · 280d
Cleared Nov 05, 2007
MEDIAID PULSE OXIMETER M30 AND M34
K071610 · DQA
Mediaid, Inc.
Anesthesiology · 145d
Cleared Nov 05, 2007
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
K071692 · MVM
Theratest Laboratories, Inc.
Immunology · 138d
Cleared Nov 05, 2007
ERBIUM FRACTIONAL HANDPIECE
K071768 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 129d
Cleared Nov 05, 2007
V-CATH POLY PICC
K071875 · LJS
Hdc Corp.
General Hospital · 122d
Cleared Nov 05, 2007
AKITA2 APIXNEB
K072019 · CAF
Activaero America, Inc.
Anesthesiology · 105d
Cleared Nov 05, 2007
GUMEASE DENTAL MOUTHPIECE
K072082 · KKO
Biomedevice , Ltd.
Dental · 98d
Cleared Nov 05, 2007
REGENEREX POROUS TITANIUM SLEEVE AUGMENTS
K072336 · JWH
Biomet Manufacturing Corp
Orthopedic · 77d
Cleared Nov 05, 2007
JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR...
K072580 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 53d
Cleared Nov 05, 2007
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
K072666 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 45d
Cleared Nov 05, 2007
IMMULITE 2500 OM-MA, MODEL L5KOP
K072794 · LTK
Siemens Medical Solutions Diagnostics
Immunology · 35d
Cleared Nov 05, 2007
ACCOLADE II LASER
K072868 · GEX
Cynosure, Inc.
General & Plastic Surgery · 27d
Cleared Nov 02, 2007
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
K070643 · KDI
Gambro, Inc.
Gastroenterology & Urology · 239d
Cleared Nov 02, 2007
ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006
K070874 · HRX
Arthro Kinetics, Inc.
Orthopedic · 218d
Cleared Nov 02, 2007
FRAXEL III SR LASER SYSTEM AND ACCESSORIES
K071051 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 203d