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
99961–99984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1995
SELECTCELLS STANDARD
K954097 · HHK
Select Medical Systems, Inc.
Obstetrics & Gynecology · 82d
Cleared Nov 21, 1995
SELECTMUCUS
K954102 · HFC
Select Medical Systems, Inc.
Obstetrics & Gynecology · 82d
Cleared Nov 21, 1995
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104 · LJS
C.R. Bard, Inc.
General Hospital · 82d
Cleared Nov 21, 1995
LOW PROFILE SAFSITE Y-SITE
K954123 · FPA
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Nov 21, 1995
DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT
K954138 · JWH
Howmedica Corp.
Orthopedic · 81d
Cleared Nov 21, 1995
MICROGLISS
K954180 · ELW
Espe GmbH & Co. Kg.
Dental · 76d
Cleared Nov 21, 1995
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K954825 · JLW
Bio-Rad Laboratories, Inc.
Chemistry · 32d
Cleared Nov 20, 1995
LEKSELL GAMMA UNIT MODEL 23004,TYPE B.
K924849 · IWB
Elekta Radiosurgery, Inc.
Radiology · 1148d
Cleared Nov 20, 1995
KEY-LOK(TM) SYSTEM
K940645 · FMI
St. Paul Medical
General Hospital · 643d
Cleared Nov 20, 1995
GRAHAM-FIELD SALINE ELECTROLYTE GEL
K944600 · GYB
Chester Labs, Inc.
Neurology · 427d
Cleared Nov 20, 1995
OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS
K945138 · DXN
Invivo Research, Inc.
Cardiovascular · 396d
Cleared Nov 20, 1995
HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100
K945400 · IZI
Hitachi Medical Corp. of America
Radiology · 382d
Cleared Nov 20, 1995
MEDIVAX
K945548 · KZE
Vitajet Corp.
General Hospital · 371d
Cleared Nov 20, 1995
CALCITONIN IMMUNOASSAY KIT
K945961 · JKR
Nichols Institute Diagnostics
Chemistry · 348d
Cleared Nov 20, 1995
MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT
K946258 · LXM
Spinalight, Inc.
Physical Medicine · 349d
Cleared Nov 20, 1995
CAD-2000 CARDIAC ASSIST DEVICE
K951124 · DRM
Eee Medical Ent.
Cardiovascular · 269d
Cleared Nov 20, 1995
THYROGLOBULIN EIA TEST KIT
K951362 · JNL
Immunoprobe, Inc.
Immunology · 241d
Cleared Nov 20, 1995
MICROSOMAL EIA TEST KIT
K951364 · JNL
Immunoprobe, Inc.
Immunology · 241d
Cleared Nov 20, 1995
HYSTEROSYS FLEXIBLE HYSTEROCOPE
K951946 · HIH
Ovamed Corp.
Obstetrics & Gynecology · 208d
Cleared Nov 20, 1995
TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)
K952467 · MHI
Trend Scientific, Inc.
Microbiology · 178d
Cleared Nov 20, 1995
COACUTE HEPARIN
K952514 · KFF
Chromogenix AB
Hematology · 173d
Cleared Nov 20, 1995
MRC-5 CELL CULTURE VIAL
K952727 · KIR
Viratest Intl., Inc.
Microbiology · 159d
Cleared Nov 20, 1995
BIOCIRCUITS IOS T4/TU TEST CARTRIDGES
K952751 · KLI
Biocircuits Corp.
Chemistry · 158d
Cleared Nov 20, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
K952818 · GMM
Pyramid Biological Corp.
Microbiology · 153d