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
86713–86736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
K984186 · DBF
Nichols Institute Diagnostics
Immunology · 71d
Cleared Feb 02, 1999
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS
K984224 · LNH
Siemens Corp.
Radiology · 69d
Cleared Feb 02, 1999
IS ANTI-TPO IGG ELISA TEST SYSTEM
K984228 · JZO
Columbia Bioscience, Inc.
Immunology · 69d
Cleared Feb 02, 1999
EWC: ECG II CABLE LEADWIRE SYSTEM
K984263 · DSA
Ewc
Cardiovascular · 64d
Cleared Feb 02, 1999
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
K984406 · OXO
Xitec, Inc.
Radiology · 55d
Cleared Feb 02, 1999
ELECSYS IGE CALCHECK
K984419 · JJY
Boehringer Mannheim Corp.
Immunology · 54d
Cleared Feb 02, 1999
QUANTEX ASO-CRP-RP CONTROL II
K984437 · JJT
Instrumentation Laboratory CO
Chemistry · 50d
Cleared Feb 02, 1999
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
K984594 · JJY
Bio-Rad
Chemistry · 36d
Cleared Feb 02, 1999
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05
K984604 · JJX
Bio-Rad
Chemistry · 36d
Cleared Feb 02, 1999
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05
K984625 · JJX
Bio-Rad
Chemistry · 36d
Cleared Feb 02, 1999
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
K990055 · JAA
Omega Medical Imaging, Inc.
Radiology · 26d
Cleared Feb 02, 1999
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH,...
K990213 · EOB
Gyrus Ent LLC
Ear, Nose, Throat · 11d
Cleared Feb 02, 1999
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
K990266 · LOS
Micromedical Industries, Ltd.
Cardiovascular · 5d
Cleared Feb 01, 1999
VECTRA COMBO
K982317 · IMG
Chattanooga Group, Inc.
Physical Medicine · 214d
Cleared Feb 01, 1999
VECTRA STIM MODELS 200 AND 400
K982321 · GZJ
Chattanooga Group, Inc.
Neurology · 214d
Cleared Feb 01, 1999
VECTRA PRO MODELS 2 AND 4
K982324 · GZJ
Chattanooga Group, Inc.
Neurology · 214d
Cleared Feb 01, 1999
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
K982385 · KRJ
Porous Media Corp.
Cardiovascular · 207d
Cleared Feb 01, 1999
GUIDEWIRE
K982559 · DQX
Galt Medical Corp.
Cardiovascular · 193d
Cleared Feb 01, 1999
CORSAIRE
K982750 · ITI
Optiway, Inc.
Physical Medicine · 179d
Cleared Feb 01, 1999
IMPLEX SCREW AND WASHER SYSTEM
K982751 · MBI
Implex Corp.
Orthopedic · 179d
Cleared Feb 01, 1999
COOK MINI-INCUBATOR
K983642 · MQG
Cook Ob/Gyn
Obstetrics & Gynecology · 108d
Cleared Feb 01, 1999
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S...
K983897 · HEE
Ri Mos. S.R.L.
Obstetrics & Gynecology · 90d
Cleared Feb 01, 1999
KSEA HF-SNARE
K983901 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 01, 1999
BARDEX LUBRI-SIL FOLEY CATHETER
K984084 · EZL
Bard Medical Div.
Gastroenterology & Urology · 77d