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
77041–77064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2002
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636,...
K020023 · MXZ
Dako Corp.
Pathology · 56d
Cleared Feb 28, 2002
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K020115 · DYH
Pulpdent Corp.
Dental · 48d
Cleared Feb 28, 2002
GC FUJI LINING LC PASTE PAK
K020117 · EMA
GC America, Inc.
Dental · 45d
Cleared Feb 28, 2002
VENUS UNIVERSAL LIGHT CURING COMPOSITE
K020131 · EBF
Heraeus Kulzer, Inc.
Dental · 44d
Cleared Feb 28, 2002
OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC)...
K020193 · LPL
Cl Mcintosh
Ophthalmic · 41d
Cleared Feb 28, 2002
JAS AMYLASE LIQUID REAGENT
K020282 · JFJ
Jas Diagnostics, Inc.
Chemistry · 31d
Cleared Feb 28, 2002
ADVANTAGE WORKSTATION 4.1
K020483 · LLZ
GE Medical Systems
Radiology · 15d
Cleared Feb 28, 2002
INFRARED EAR THERMOMETER, MODELS TH88 SERIES
K020504 · FLL
Radiant Innovation, Inc.
General Hospital · 13d
Cleared Feb 27, 2002
DIODENT DENTAL LASER SYSTEM
K013216 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 154d
Cleared Feb 27, 2002
INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC...
K013651 · DSY
Intervascular
Cardiovascular · 113d
Cleared Feb 27, 2002
PULSION FS LASER KERATOME
K013941 · GEX
Intra Lase Corp.
General & Plastic Surgery · 90d
Cleared Feb 27, 2002
FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
K013946 · NEY
Afx, Inc.
General & Plastic Surgery · 90d
Cleared Feb 27, 2002
LIFESTITCH SUTURING DEVICE
K013990 · GAT
Edwards Lifesciences, LLC
General & Plastic Surgery · 86d
Cleared Feb 27, 2002
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059 · DYH
Pulpdent Corp.
Dental · 79d
Cleared Feb 27, 2002
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
K014115 · BTM
Portex, Inc.
Anesthesiology · 75d
Cleared Feb 27, 2002
PADPRO, MODEL 2603
K020288 · MKJ
Padpro, LLC
Cardiovascular · 30d
Cleared Feb 27, 2002
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
K020291 · JDI
Exactech, Inc.
Orthopedic · 30d
Cleared Feb 27, 2002
STEALTHSTATION WITH FLUOROMERGE SOFTWARE
K020338 · HAW
Medtronic Surgical Navigation...
Neurology · 26d
Cleared Feb 27, 2002
DEPILASE YAG LASE PLUS LASER SYSTEM
K020463 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 15d
Cleared Feb 26, 2002
RUSCH MILLER-ABBOTT TUBE
K010797 · KNT
Rusch Intl.
Gastroenterology & Urology · 347d
Cleared Feb 26, 2002
RUSCH CANTOR TUBE
K010798 · KNT
Rusch Intl.
Gastroenterology & Urology · 347d
Cleared Feb 26, 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K013107 · HWC
Karl Storz Endoscopy
Orthopedic · 162d
Cleared Feb 26, 2002
WIN-2 TANGO ELITE NP
K013361 · ITI
Durable Medical Equipment, Inc.
Physical Medicine · 139d
Cleared Feb 26, 2002
LASER SYSTEM YELLOWSTAR
K013940 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 89d