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
78025–78048 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2001
OPTIBOND SOLO PLUS ACTIVATOR
K012082 · KLE
Sybron Dental Specialties, Inc.
Dental · 79d
Cleared Sep 20, 2001
PRECLUDE PERICARDIAL MEMBRANE
K012098 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Sep 20, 2001
PATTON ENDO-BAG
K012150 · GCJ
Patton Medical Corp.
General & Plastic Surgery · 72d
Cleared Sep 20, 2001
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
K013018 · MID
Corgenix, Inc.
Immunology · 13d
Cleared Sep 20, 2001
QUANTUM VERSATILITY IMPLANT SYSTEM
K991250 · DZE
Quantum Bioengineering, Ltd.
Dental · 891d
Cleared Sep 19, 2001
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
K003620 · DZE
Nsi
Dental · 301d
Cleared Sep 19, 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · FMF
Orthovita, Inc.
General Hospital · 162d
Cleared Sep 19, 2001
NEUROSOFT'S SOURCE
K011241 · OLX
Neurosoft, Inc.
Neurology · 149d
Cleared Sep 19, 2001
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943 · LZN
Kensey Nash Corp.
Orthopedic · 90d
Cleared Sep 19, 2001
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
K011944 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 90d
Cleared Sep 19, 2001
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · HSX
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Sep 19, 2001
HORIZON OUTLOOK WITH DOSECOM
K011975 · FRN
B.Braun Medical, Inc.
General Hospital · 86d
Cleared Sep 19, 2001
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
K011996 · HIL
Procter & Gamble Co.
Obstetrics & Gynecology · 84d
Cleared Sep 19, 2001
RHS HELMET
K012007 · MVA
Restorative Health Svs, Inc.
Neurology · 84d
Cleared Sep 19, 2001
3I CALCIUM SULFATE BONE CEMENT
K012047 · LYC
Implant Innovations, Inc.
Dental · 82d
Cleared Sep 19, 2001
GEODESIC EEG SYSTEM, MODEL 200
K012079 · GWQ
Electrical Geodesics, Incorporated
Neurology · 78d
Cleared Sep 19, 2001
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
K012124 · GAP
Johnson & Johnson Medical (China) , Ltd.
General & Plastic Surgery · 75d
Cleared Sep 19, 2001
LOWSLEY SUPRAPUBIC TRACTOR
K012153 · KOB
Circon Video
Gastroenterology & Urology · 70d
Cleared Sep 19, 2001
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K012154 · LNH
Aurora Imaging Technology, Inc.
Radiology · 70d
Cleared Sep 19, 2001
OLDELFT THORASCAN MODEL NUMBER 180T
K012165 · KPR
Nucletron Corp.
Radiology · 70d
Cleared Sep 19, 2001
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · GAT
Aesculap, Inc.
General & Plastic Surgery · 68d
Cleared Sep 19, 2001
WIENER LAB. UREA UV CINETICA AA
K012260 · CDQ
Wiener Laboratories Saic
Chemistry · 63d
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · KXT
Diagnostic Products Corp.
Toxicology · 61d
Cleared Sep 19, 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334 · MAI
Bionx Implants, Inc.
Orthopedic · 57d