FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76441–76464 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 26, 2002
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE...
K013953 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 88d
Cleared Feb 26, 2002
ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
K013973 · LPL
Vistakon
Ophthalmic · 85d
Cleared Feb 26, 2002
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL,...
K013996 · LYY
Pt. Maja Agung Latexindo
General Hospital · 85d
Cleared Feb 26, 2002
VINYL EXAMINATION GLOVES STERILE POWEDERED
K020044 · LYZ
Primus Gloves Private , Ltd.
General Hospital · 50d
Cleared Feb 26, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020132 · DXZ
Chase Medical, Inc.
Cardiovascular · 42d
Cleared Feb 26, 2002
MEDIAL ROTATION KNEE SYSTEM
K020214 · JWH
Engineering Consulting Services, Inc.
Orthopedic · 35d
Cleared Feb 26, 2002
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
K020351 · DTZ
Dideco S.P.A.
Cardiovascular · 22d
Cleared Feb 26, 2002
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
K020352 · HWC
Unitedstates Surgical
Orthopedic · 22d