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
86233–86256 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1999
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K990193 · KXK
Implant Sciences Corp.
Radiology · 119d
Cleared May 20, 1999
LIFE IMAGING SYSTEMS, MODEL L3DI
K990560 · IYO
Life Imaging Systems, Inc.
Radiology · 87d
Cleared May 20, 1999
POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES
K990690 · LYY
Top Glove Sdn. Bhd.
General Hospital · 78d
Cleared May 20, 1999
BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES
K990710 · KGO
Barriermed Glove Co.
General Hospital · 77d
Cleared May 20, 1999
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 66d
Cleared May 20, 1999
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
K991057 · MOS
Toshiba America Mri, Inc.
Radiology · 51d
Cleared May 20, 1999
VITRON H
K991220 · EBI
Espe Dental AG
Dental · 38d
Cleared May 20, 1999
VESTOGUM
K991221 · ELW
Espe Dental AG
Dental · 38d
Cleared May 20, 1999
AII-PRO 100 PLUS AND ALL-PRO 200
K991435 · IXW
All-Pro Imaging Corp.
Radiology · 24d
Cleared May 19, 1999
VECTORVISION2
K983831 · HAW
Brainlab AG
Neurology · 201d
Cleared May 19, 1999
OSTEOGRAM BONE DENSITOMETER
K984285 · KGI
Compumed, Inc.
Radiology · 169d
Cleared May 19, 1999
BIPAP HARMONY S/T, MODEL 1001445
K984407 · MNS
Respironics, Inc.
Anesthesiology · 161d
Cleared May 19, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
K990016 · JJY
Ortho-Clinical Diagnostics, Inc.
Immunology · 135d
Cleared May 19, 1999
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE...
K990522 · OLV
Lamont Medical, Inc.
Neurology · 90d
Cleared May 19, 1999
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
K990538 · HCC
Brainmaster
Neurology · 89d
Cleared May 19, 1999
VISTA STEREOSCOPE SYSTEM
K990635 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 82d
Cleared May 19, 1999
GALLINI ATRA-CUT NEEDLE
K990645 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 82d
Cleared May 19, 1999
EASTGATE PERSONAL MONITOR
K990731 · GCJ
Eastgate Trading Corp.
General & Plastic Surgery · 75d
Cleared May 19, 1999
ETB TROCAR SYSTEM
K990894 · GCJ
The Altomec Corp.
General & Plastic Surgery · 62d
Cleared May 19, 1999
ACP
K991010 · CKB
Abbott Diagnostics Mfg., Inc.
Chemistry · 54d
Cleared May 19, 1999
VACUTAINER BRAND CTAD TUBE (MULTIPLE)
K991120 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 47d
Cleared May 19, 1999
MODIFICATION OF N/T PROTEIN CONTROL SL
K991182 · JJY
Dade Behring, Inc.
Chemistry · 42d
Cleared May 19, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
K991364 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 29d
Cleared May 19, 1999
ELAN ALKALINE PHOSPHATE REAGENT KIT
K991387 · CJE
Elan Holdings, Inc.
Chemistry · 28d