FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76081–76104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2002
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
K013223 · CAW
Litton Systems, Inc.
Anesthesiology · 137d
Cleared Feb 11, 2002
LUMEND FRONTRUNNER CTO CORONARY CATHETER
K013284 · DQY
Lumend, Inc.
Cardiovascular · 132d
Cleared Feb 11, 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K013479 · LPN
Allergan, Inc.
Ophthalmic · 115d
Cleared Feb 11, 2002
TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH)
K013635 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 98d
Cleared Feb 11, 2002
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
K013722 · IYN
Hitachi Medical Corp.
Radiology · 94d
Cleared Feb 11, 2002
TEKNO-MEDICAL OBSTETRICAL FORCEPS
K013747 · HDA
Tekno Medical Optik-Chirurgie GmbH & Co.
Obstetrics & Gynecology · 90d
Cleared Feb 11, 2002
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)
K013748 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Feb 11, 2002
ENDOANCHOR AND OPENANCHOR
K013749 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 90d
Cleared Feb 11, 2002
DC-3300 LASER DIODE PHOTOCOAGULATOR
K013760 · HQF
Nidek, Inc.
Ophthalmic · 90d
Cleared Feb 11, 2002
SPIROLAB II, MODEL 29
K013812 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 88d
Cleared Feb 11, 2002
JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
K013944 · DWF
Jostra AG
Cardiovascular · 74d
Cleared Feb 11, 2002
CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS
K014048 · GEX
Clinicon Corp.
General & Plastic Surgery · 66d
Cleared Feb 11, 2002
MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K014301 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 42d
Cleared Feb 11, 2002
BRACE EZE
K020009 · EGD
Udent, Inc.
Dental · 40d
Cleared Feb 11, 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052 · FGE
Cordis Corp.
Gastroenterology & Urology · 34d
Cleared Feb 11, 2002
MODIFICATION TO TRANSSEPTAL INTRODUCER SET
K020090 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 32d
Cleared Feb 11, 2002
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST...
K020138 · KHG
Gds Technology
Hematology · 26d
Cleared Feb 11, 2002
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
K020170 · LPH
Encore Orthopedics, Inc.
Orthopedic · 25d
Cleared Feb 11, 2002
MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
K020281 · NHK
Ventlab Corp.
Anesthesiology · 14d
Cleared Feb 11, 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · DQX
Boston Scientific Corp
Cardiovascular · 14d
Cleared Feb 08, 2002
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
K012562 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 184d
Cleared Feb 08, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · HAW
Smith & Nephew, Inc.
Neurology · 161d
Cleared Feb 08, 2002
OMEGATRAC, MODEL Z105
K013307 · ITI
Teftec Corp.
Physical Medicine · 127d
Cleared Feb 08, 2002
CONCERT RADIOPAQUE BONE CEMENT
K013755 · LOD
Immedica, Inc.
Orthopedic · 87d