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
74089–74112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2002
POLY-CARB
K022030 · EBG
Inovativ, LLC
Dental · 68d
Cleared Aug 28, 2002
RF TENT
K022157 · LNH
Odin Medical Technologies , Ltd.
Radiology · 57d
Cleared Aug 28, 2002
MODIFICATION TO TENOR SPINAL SYSTEM
K022191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 54d
Cleared Aug 28, 2002
HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS
K022334 · MQL
Intl., Inc.
Obstetrics & Gynecology · 41d
Cleared Aug 28, 2002
HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
K022352 · MQL
Intl., Inc.
Obstetrics & Gynecology · 40d
Cleared Aug 28, 2002
SPERMASSIST
K022443 · MQL
Nidacon International AB
Obstetrics & Gynecology · 34d
Cleared Aug 28, 2002
ACIDIFIED TYRODES SOLUTION
K022547 · MQL
Intl., Inc.
Obstetrics & Gynecology · 27d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 28, 2002
VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
K022718 · GEI
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 13d
Cleared Aug 28, 2002
7F LAUNCHER GUIDE CATHETER
K022764 · DQY
Medtronic Vascular
Cardiovascular · 7d
Cleared Aug 28, 2002
THE AUTOTAC SYSTEM TITANIUM TACK
K022790 · DZL
BioHorizons Implant Systems, Inc.
Dental · 6d
Cleared Aug 27, 2002
3A DENTAL IMPLANT SYSTEM
K011879 · DZE
Osseco Biosource, Ltd.
Dental · 438d
Cleared Aug 27, 2002
PALMLIGHT
K020057 · EBZ
CAO Group, Inc.
Dental · 231d
Cleared Aug 27, 2002
APL IGA ELISA KIT
K021398 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 117d
Cleared Aug 27, 2002
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
K021759 · MSD
Medcomp
Gastroenterology & Urology · 90d
Cleared Aug 27, 2002
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
K021760 · HAW
Orthosoft, Inc.
Neurology · 90d
Cleared Aug 27, 2002
PROTEIN S AC
K022290 · GGP
Dade Behring, Inc.
Hematology · 43d
Cleared Aug 27, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K022491 · JJX
Cliniqa Corporation
Chemistry · 29d
Cleared Aug 27, 2002
FONIX, MODEL 7000
K022510 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 27, 2002
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550 · JBQ
Instrumentation Laboratory CO
Hematology · 25d
Cleared Aug 27, 2002
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
K022623 · KWP
Depuyacromed
Orthopedic · 20d
Cleared Aug 27, 2002
TAILWIND
K022704 · ITI
Deltaglide
Physical Medicine · 13d
Cleared Aug 26, 2002
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
K020529 · KFM
A-Med Systems, Inc.
Cardiovascular · 188d
Cleared Aug 26, 2002
REPHRESH VAGINAL GEL
K021737 · NUC
Columbia Laboratories, Inc.
Obstetrics & Gynecology · 90d