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
87217–87240 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1999
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR
K990157 · IOR
Invacare Corp.
Physical Medicine · 15d
Cleared Feb 02, 1999
EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA
K980631 · DXC
Embol-X, Inc.
Cardiovascular · 349d
Cleared Feb 02, 1999
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
K981725 · BZQ
Optovent, Inc.
Anesthesiology · 263d
Cleared Feb 02, 1999
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
K982307 · JNB
Wallac, Inc.
Chemistry · 216d
Cleared Feb 02, 1999
MEROGEL NASAL DRESSING AND SINUS STENT
K982731 · EMX
Xomed, Inc.
Ear, Nose, Throat · 181d
Cleared Feb 02, 1999
OSTEOMARK NTX SERUM EIA
K983457 · JMM
Ostex Intl., Inc.
Chemistry · 125d
Cleared Feb 02, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC...
K983690 · MOI
Ortho-Clinical Diagnostics, Inc.
Immunology · 104d
Cleared Feb 02, 1999
ANTI-TPO EIA DIAGNOSTIC TEST KIT
K984163 · JZO
The Binding Site, Ltd.
Immunology · 74d
Cleared Feb 02, 1999
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
K984165 · JZO
The Binding Site, Ltd.
Immunology · 74d
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