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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
147457–147480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1985
PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER
K851848 · LIT
Mansfield Scientific, Inc.
Cardiovascular · 84d
Cleared Jul 19, 1985
TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS
K851891 · LOJ
Richard Scott Elliott
Immunology · 80d
Cleared Jul 19, 1985
SEA MED DDD PACING SYSTEM ANALYZER
K851900 · DTC
Seamed Corp.
Cardiovascular · 80d
Cleared Jul 19, 1985
REMOTE SPEED CONTROL
K851946 · ISD
Th Charters, Inc.
Physical Medicine · 77d
Cleared Jul 19, 1985
TORQUE FEEDBACK METER
K851967 · ISD
Th Charters, Inc.
Physical Medicine · 74d
Cleared Jul 19, 1985
JYROCHAIR, MODEL SK-H
K852015 · ITI
Medco Products, Co., Inc.
Physical Medicine · 71d
Cleared Jul 19, 1985
CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI
K852044 · LLH
Marion Laboratories, Inc.
Microbiology · 71d
Cleared Jul 19, 1985
PRESTON LOWER LIMB CPM UNIT
K852065 · BXB
Therapeutic Equipment Corp.
Physical Medicine · 67d
Cleared Jul 19, 1985
TEMREX DENTAL POLISHING PASTE
K852157 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 63d
Cleared Jul 19, 1985
EBI FOOT MASSAGING PUMP
K852264 · IRP
Electro-Biology, Inc.
Physical Medicine · 56d
Cleared Jul 19, 1985
CMT 1000
K852390 · KQX
Prestigeline, Inc.
Neurology · 44d
Cleared Jul 19, 1985
SUPRIMA II MODEL 254-26
K852431 · DXY
Intermedics, Inc.
Cardiovascular · 39d
Cleared Jul 19, 1985
MICRO-FOCUS 50 CABINET X-RAY
K852634 · MWP
Micro-Focus Imaging., Inc.
Radiology · 29d
Cleared Jul 19, 1985
MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM
K852677 · BZG
Alpha Technologies, Inc.
Anesthesiology · 25d
Cleared Jul 19, 1985
FISHER DIAGNOSTIC LATEST ASO TEST KIT
K852701 · GTQ
Allied Fisher Scientific
Immunology · 23d
Cleared Jul 19, 1985
AEROMONAS AGAR(XDCA)
K852789 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 18d
Cleared Jul 19, 1985
IDENTICULT-NEISSERIA
K852832 · JTO
Scott Laboratories, Inc.
Microbiology · 17d
Cleared Jul 18, 1985
MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE
K850269 · LIQ
Meridian Diagnostics, Inc.
Microbiology · 176d
Cleared Jul 18, 1985
ADAC MODELS XL-PLAN 23 & XL-PLAN 73
K851041 · IYE
Adac Laboratories
Radiology · 126d
Cleared Jul 18, 1985
SATURN NUCLEAR MEDICINE COMPUTER SYSTEM
K852089 · IYX
Technicare Corp.
Radiology · 66d
Cleared Jul 18, 1985
RADIOLOGICAL MARKING PEN
K852160 · JAC
Truett Laboratories, Inc.
Radiology · 140d
Cleared Jul 18, 1985
SRT-SYSTEM
K852554 · JPH
Microwave Development, Inc.
Hematology · 31d
Cleared Jul 17, 1985
NEUROSCIENCE MAP-10 EEG
K850430 · GWS
Neuroscience, Inc.
Neurology · 163d
Cleared Jul 17, 1985
KINETIC AUTO TECHNIC K.A.T. TABLE
K851328 · JFB
Buckman Co., Inc.
Physical Medicine · 104d