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
84601–84624 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1999
COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION
K993517 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Nov 01, 1999
SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM
K984203 · IYN
Shantou Institute of Ultrasonic...
Radiology · 342d
Cleared Nov 01, 1999
QUANTECH CK-MB ASSAY
K984433 · MYT
Quantech , Ltd.
Chemistry · 322d
Cleared Nov 01, 1999
ABSOGEL CHEMOTHERAPHY GLOVES
K990677 · LZC
Ampri Rubberware Industries Sdn Bhd
General Hospital · 244d
Cleared Nov 01, 1999
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
K990826 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 234d
Cleared Nov 01, 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · LCP
Abbott Laboratories
Hematology · 187d
Cleared Nov 01, 1999
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
K992323 · MLD
Datex-Ohmeda, Inc.
Cardiovascular · 112d
Cleared Nov 01, 1999
ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION...
K992512 · DZE
Imcor
Dental · 97d
Cleared Nov 01, 1999
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K992599 · DTN
Dideco S.P.A.
Cardiovascular · 90d
Cleared Nov 01, 1999
IL TEST VON WILLEBRAND FACTOR
K992704 · GGP
Instrumentation Laboratory CO
Hematology · 81d
Cleared Nov 01, 1999
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
K992976 · DDR
Kamiya Biomedical Co.
Chemistry · 59d
Cleared Nov 01, 1999
MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA)...
K993034 · MVM
Medica, Inc.
Immunology · 53d
Cleared Nov 01, 1999
RAPICURE 200 (CURING AND WHITENING LIGHT)
K993223 · EBZ
Mediphotonix, LC
Dental · 35d
Cleared Nov 01, 1999
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
K993387 · FRN
Baxter Healthcare Corp
General Hospital · 24d
Cleared Nov 01, 1999
HRW WRIST ARRAY COIL
K993477 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 29, 1999
DR. JAHANGER'S CUTTER
K990738 · KNA
M.S. Jahanger, MD
Obstetrics & Gynecology · 238d
Cleared Oct 29, 1999
NUTRISAFE EXTENSION TUBE
K991918 · KNT
Vygon Corp.
Gastroenterology & Urology · 144d
Cleared Oct 29, 1999
MAPS 10000
K992560 · KPS
Web Link Medical
Radiology · 88d
Cleared Oct 29, 1999
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM...
K992574 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 88d
Cleared Oct 29, 1999
MASS (MICRO-ACCESS SPINE SYSTEM)
K992583 · HRX
Omni-Tract Surgical, Div. Minn....
Orthopedic · 88d
Cleared Oct 29, 1999
KONICA LASER IMAGER, DRYPRO MODEL 722
K992586 · LMC
Konica Corp.
Radiology · 88d
Cleared Oct 29, 1999
RESPALERT
K992618 · BZH
Harwill Medical (Pty) , Ltd.
Anesthesiology · 86d
Cleared Oct 29, 1999
ATD AUTOMATIC BRIDGE REMOVER
K992649 · EIS
J. Morita USA, Inc.
Dental · 84d
Cleared Oct 29, 1999
TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES
K992841 · LZA
Tg Medical Sdn. Bhd.
General Hospital · 66d