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
82033–82056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2000
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS...
K000303 · JOW
Healthcare Service and Supply
Cardiovascular · 105d
Cleared May 16, 2000
C-IT
K000520 · CCK
Bregas AB
Anesthesiology · 90d
Cleared May 16, 2000
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
K000621 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 89d
Cleared May 16, 2000
SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
K000623 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 89d
Cleared May 16, 2000
UMECO OPTIMA MULTILINE LASER SYSTEM
K000693 · GEX
Medical Laser Solutions, LLC
General & Plastic Surgery · 76d
Cleared May 16, 2000
PROVIEW MEDICAL IMAGE DISPLAY MODULE
K000770 · LLZ
Cerner Corp.
Radiology · 68d
Cleared May 16, 2000
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K001013 · OLV
Airsep Corp.
Neurology · 48d
Cleared May 16, 2000
OPTIVU HDVD SYSTEM
K001169 · GCJ
Optimize, Inc.
General & Plastic Surgery · 35d
Cleared May 16, 2000
ENDOPATH SURESEAL REDUCER CAP
K001220 · HET
Ethicon Endo-Surgery, Inc.
Obstetrics & Gynecology · 29d
Cleared May 16, 2000
ALL-PRO 2010
K001321 · IXW
All-Pro Imaging Corp.
Radiology · 20d
Cleared May 16, 2000
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
K001438 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 8d
Cleared May 16, 2000
APOLLO MULTI-RACIAL REFERENCE POPULATION
K993337 · KGI
Norland Medical Systems, Inc.
Radiology · 224d
Cleared May 16, 2000
THE STRIPPER
K993699 · MQH
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 196d
Cleared May 15, 2000
JETLITE 4000
K000078 · EBZ
J. Morita USA, Inc.
Dental · 125d
Cleared May 15, 2000
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
K000179 · KGO
Terang Nusa Sdn Bhd
General Hospital · 116d
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