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
82561–82584 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2000
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
K000399 · LCM
OraSure Technologies, Inc.
Toxicology · 98d
Cleared May 15, 2000
STRYKER IRRIGATION TUBE SET
K000493 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 90d
Cleared May 15, 2000
MEDART 520 COOLING SYSTEM
K000503 · GEX
Medart Corp.
General & Plastic Surgery · 90d
Cleared May 15, 2000
ART-M1, MODEL M1-1-ART-A1
K000510 · ELC
Bonart Co., Ltd.
Dental · 90d
Cleared May 15, 2000
SOLO-CARE BRAND HARD SOLUTION
K000607 · MRC
Ciba Vision Corporation
Ophthalmic · 82d
Cleared May 15, 2000
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
K000926 · CGZ
Medica Corp.
Chemistry · 54d
Cleared May 15, 2000
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000928 · JTN
Oxoid , Ltd.
Microbiology · 54d
Cleared May 15, 2000
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM...
K001232 · LYY
Fitco Dipped Products Pvt., Ltd.
General Hospital · 28d
Cleared May 15, 2000
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K001239 · KGO
Ansell Perry
General Hospital · 27d
Cleared May 15, 2000
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH...
K001280 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 24d
Cleared May 15, 2000
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI...
K001444 · JOJ
Steritec Products, Inc.
General Hospital · 7d
Cleared May 15, 2000
BVBLUE
K993732 · MXB
Gryphus Diagnostics, LLC
Chemistry · 193d
Cleared May 15, 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200...
K993760 · LYY
Hartalega Sdn Bhd
General Hospital · 189d
Cleared May 15, 2000
ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
K994334 · DYB
Daig Corp.
Cardiovascular · 144d
Cleared May 12, 2000
METRISCAN BONE DENSITY SYSTEM
K000162 · KGI
Alara, Inc.
Radiology · 114d
Cleared May 12, 2000
WALLSTENT ENTERNAL PROSTHESIS
K000281 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 102d
Cleared May 12, 2000
HYDRO2, HS-75
K000485 · HQD
Innovision, Inc.
Ophthalmic · 88d
Cleared May 12, 2000
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
K000630 · LLZ
Hopkins Imaging Systems, Inc.
Radiology · 78d
Cleared May 12, 2000
PHILIPS CT SECURA MV
K000819 · JAK
Philips Medical Systems North...
Radiology · 60d
Cleared May 12, 2000
URETHROTOME 8667.XXX AND 8670.XXX
K000905 · EZO
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 52d
Cleared May 12, 2000
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9,...
K000915 · MQK
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 51d
Cleared May 12, 2000
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
K000948 · FEQ
Keymed (Medical & Industrial...
Gastroenterology & Urology · 50d
Cleared May 12, 2000
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
K000950 · MQF
Labotect Labor-Technik Gottingen
Obstetrics & Gynecology · 50d
Cleared May 12, 2000
DELTA 16 TACT
K001171 · IZH
Instrumentarium Imaging, Inc.
Radiology · 31d