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
119617–119640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1991
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1
K914069 · MSJ
Medical Analysis Systems, Inc.
Immunology · 21d
Cleared Oct 01, 1991
HANN-VAC TM, DISPOSABLE,SUCTION CATHETER
K903480 · BSY
Un-I-Med, Inc.
Anesthesiology · 425d
Cleared Sep 30, 1991
MEDISENSOR 2001
K903564 · JGS
Medtest Systems, Inc.
Chemistry · 419d
Cleared Sep 30, 1991
MEMFIX SCREWS
K910427 · DZL
W.L. Gore & Associates, Inc.
Dental · 241d
Cleared Sep 30, 1991
IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000
K911194 · DSB
Rjl Systems, Inc.
Cardiovascular · 196d
Cleared Sep 30, 1991
PHOENIX DIGITAL EEG SYSTEM
K911229 · GWQ
Dantec Medical, Inc.
Neurology · 194d
Cleared Sep 30, 1991
FLUX-N-ALL
K911323 · EJH
Precident Corp.
Dental · 189d
Cleared Sep 30, 1991
DENTAL FLOSS
K912430 · JES
Westone Products , Ltd.
Dental · 122d
Cleared Sep 30, 1991
GAUZE SPONGE,STERILE 2'S
K912779 · NAB
Keilei Intl., Inc.
General & Plastic Surgery · 98d
Cleared Sep 30, 1991
LARYNGOSCOPE
K912905 · CCW
Acorn Group, Inc.
Anesthesiology · 90d
Cleared Sep 30, 1991
GAUZE COMPRESS
K912953 · NAB
Cal West Trading Co.
General & Plastic Surgery · 90d
Cleared Sep 30, 1991
INSTRUMENTARIUM MEGA4
K912963 · LNH
Instrumentarium Imaging, Inc.
Radiology · 84d
Cleared Sep 30, 1991
MAX-I-PROBE IRRIGATION SYSTEM
K913030 · EFS
Smith & Nephew, Inc.
Dental · 83d
Cleared Sep 30, 1991
DENTAL FLOSS
K913087 · JES
Westone Products , Ltd.
Dental · 80d
Cleared Sep 30, 1991
SILICONE GEL SHEETING
K913140 · MDA
Cui Corp.
General & Plastic Surgery · 76d
Cleared Sep 30, 1991
WHITER BITER CROWN
K913152 · ELZ
George M. Wilson, Dds
Dental · 75d
Cleared Sep 30, 1991
CYTOLOGY BRUSH
K913248 · FDX
Annex Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Sep 30, 1991
ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER
K913469 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 56d
Cleared Sep 30, 1991
SEPTOCAL CAVITY LINER
K913574 · EJK
Specialites Septodont
Dental · 49d
Cleared Sep 30, 1991
FIBRETWINS
K913603 · KNT
Oral-B Laboratories
Gastroenterology & Urology · 47d
Cleared Sep 30, 1991
AIA-PACK T-U
K913663 · KHQ
Tosoh Corp.
Chemistry · 45d
Cleared Sep 30, 1991
MICROTAK PLUS
K913840 · JJQ
Syva Co.
Chemistry · 35d
Cleared Sep 30, 1991
PROLACTIN IRMA IMMUNOMAG
K914107 · CFT
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 17d
Cleared Sep 27, 1991
PROSPEC T/GIARDIA RAPID ASSAY
K911337 · MHI
Alexon, Inc.
Microbiology · 185d