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
84001–84024 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1999
DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)
K992482 · GEX
Radiancy, Ltd.
General & Plastic Surgery · 154d
Cleared Dec 27, 1999
SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST
K992949 · LDJ
Drug Detection Devices, Ltd.
Toxicology · 117d
Cleared Dec 27, 1999
ELITE CUSTOM
K993142 · LKY
Soma Blue, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 27, 1999
VITALITY SYSTEM
K993143 · LKY
Soma Blue, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 27, 1999
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF...
K993485 · DIO
Sun Biomedical Laboratories, Inc.
Chemistry · 74d
Cleared Dec 27, 1999
CARESIDE DIRECT BILIRUBIN
K993771 · CIG
Careside, Inc.
Chemistry · 49d
Cleared Dec 27, 1999
SODEM PERFORATOR DRIVE
K993851 · HBB
Sodemsystems
Neurology · 45d
Cleared Dec 27, 1999
K-ASSAY MULTI-ANALYTE CALIBRATOR
K993853 · JIX
Kamiya Biomedical Co.
Chemistry · 45d
Cleared Dec 27, 1999
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE,...
K993936 · KNW
Imagyn Surgical
Gastroenterology & Urology · 38d
Cleared Dec 27, 1999
HARDYDISK AMIKACIN 30MCG
K993993 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Dec 27, 1999
GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435
K994075 · GEI
Geiger Medical Technologies, Inc.
General & Plastic Surgery · 25d
Cleared Dec 27, 1999
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · GWJ
Bio-Logic Systems Corp.
Neurology · 19d
Cleared Dec 27, 1999
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
K994166 · KNS
Gyrus Medical , Ltd.
Gastroenterology & Urology · 18d
Cleared Dec 23, 1999
FASTSEAL CHEST WOUND DRESSING
K990079 · MGP
Greenfield Medical Technologies, Inc.
General & Plastic Surgery · 346d
Cleared Dec 23, 1999
OMNICORDER BIOSCAN SYSTEM
K990416 · LHQ
Omnicorder Technologies, Inc.
Radiology · 316d
Cleared Dec 23, 1999
PHARMASEED, MODEL BT-125-1
K992008 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 191d
Cleared Dec 23, 1999
MPM REGENECARE WOUND GEL
K992074 · MGQ
Mpm Medical., Inc.
General & Plastic Surgery · 188d
Cleared Dec 23, 1999
SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE...
K993209 · GEX
Thermolase Corp.
General & Plastic Surgery · 90d
Cleared Dec 23, 1999
DUCPREP BREAST ASPIRATOR, MODEL PMPO2
K993342 · KNW
Windy Hill Technology, Inc.
Gastroenterology & Urology · 79d
Cleared Dec 23, 1999
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP
K993424 · FZP
Y-Clip Associates
General & Plastic Surgery · 72d
Cleared Dec 23, 1999
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
K993651 · GBM
Sc Hennig Enterprises Europe Srl
Gastroenterology & Urology · 55d
Cleared Dec 23, 1999
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K993731 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Dec 23, 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068 · FGE
Cordis Corp.
Gastroenterology & Urology · 21d
Cleared Dec 22, 1999
GUGLIELMI DETACHABLE (GDC)
K991139 · HCG
Boston Scientific, Target
Neurology · 261d