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
87889–87912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1998
SULLIVAN MIRAGE FULL FACE MASK
K982530 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Oct 16, 1998
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
K982531 · HRS
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 16, 1998
QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150
K982621 · MVO
Phamatech
Toxicology · 80d
Cleared Oct 16, 1998
TRACCELL 2000 SLIDE MAPPING SYSTEM
K982786 · JOY
Accumed Intl., Inc.
Hematology · 67d
Cleared Oct 16, 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES...
K982866 · JZO
Nichols Institute Diagnostics
Immunology · 63d
Cleared Oct 16, 1998
B-SYSTEM SILICONE
K982917 · ELW
Sybron Dental Specialties, Inc.
Dental · 58d
Cleared Oct 16, 1998
GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE
K982999 · JKA
Greiner Meditech, Inc.
Chemistry · 50d
Cleared Oct 16, 1998
MYSTIQUE ULTRASONIC NEBULIZER
K983002 · CAF
Airsep Corp.
Anesthesiology · 49d
Cleared Oct 16, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1
K983409 · FOZ
Hdc Corp.
General Hospital · 18d
Cleared Oct 15, 1998
VINYL PATIENT EXAMINATION GLOVE, POWDERED
K981360 · LYZ
Glormed Intl., Inc.
General Hospital · 184d
Cleared Oct 15, 1998
BIOCLEAR CONCENTRATE
K981565 · EIA
Waggoner Product Development
Dental · 167d
Cleared Oct 15, 1998
SMOKE-EVAC
K981888 · GEI
Bio-Medical Devices, Inc.
General & Plastic Surgery · 139d
Cleared Oct 15, 1998
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
K982209 · GJA
Sigma Diagnostics, Inc.
Hematology · 114d
Cleared Oct 15, 1998
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
K982220 · DTD
Medtronic Vascular
Cardiovascular · 113d
Cleared Oct 15, 1998
IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES
K982492 · DZE
Imcor
Dental · 90d
Cleared Oct 15, 1998
AUROFLUID CPF
K982606 · EJT
Metalor Dental USA Corp.
Dental · 80d
Cleared Oct 15, 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · EIA
KARL STORZ Endoscopy-America, Inc.
Dental · 77d
Cleared Oct 15, 1998
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
K982680 · MOI
Chiron Diagnostics Corp.
Immunology · 76d
Cleared Oct 15, 1998
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL
K982772 · MOS
Ge Medical Systems, Inc.
Radiology · 69d
Cleared Oct 15, 1998
FILM DIGITIZER MODEL 2905
K982785 · LMA
Array Corp.
Radiology · 69d
Cleared Oct 15, 1998
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50...
K982872 · LYY
Tg Medical Sdn. Bhd.
General Hospital · 62d
Cleared Oct 15, 1998
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
K982879 · MSV
Shield Diagnostics, Ltd.
Immunology · 62d
Cleared Oct 15, 1998
IMMULITE 2000 OM-MA MODEL L2KOP2
K983391 · LTK
Diagnostic Products Corp.
Immunology · 20d
Cleared Oct 14, 1998
VGF-7 VASCULAR GRAFT FLOWMETER
K973198 · DPW
Medicard , Ltd.
Cardiovascular · 414d