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
77737–77760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
K012561 · JJX
Ortho-Clinical Diagnostics
Microbiology · 21d
Cleared Aug 29, 2001
E-SCAN MRI SYSTEM
K012728 · MOS
Biosound Esaote, Inc.
Radiology · 14d
Cleared Aug 28, 2001
POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)
K002172 · GAT
Xiros Plc
General & Plastic Surgery · 405d
Cleared Aug 28, 2001
ACCU-PULSE TENS UNIT
K010203 · GZJ
Sadler Electronics
Neurology · 218d
Cleared Aug 28, 2001
ORTELIUS 800
K011827 · KQX
Orthoscan , Ltd.
Neurology · 77d
Cleared Aug 28, 2001
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K011844 · CAW
Merits Health Products., Inc.
Anesthesiology · 77d
Cleared Aug 28, 2001
SNIPER ELITE MODEL-OR-E3872XX SERIES
K011905 · DQX
Maxxim Medical
Cardiovascular · 70d
Cleared Aug 28, 2001
TRULINE INFUSION CATHETERS
K011937 · FOZ
Micro Therapeutics, Inc.
General Hospital · 68d
Cleared Aug 28, 2001
BI-PHASIC INFILTRATOR
K012044 · FRN
Reliance Medical Corp.
General Hospital · 60d
Cleared Aug 28, 2001
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K012083 · DQY
Medtronic Vascular
Cardiovascular · 56d
Cleared Aug 28, 2001
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
K012130 · DQY
Medtronic Vascular
Cardiovascular · 50d
Cleared Aug 28, 2001
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225 · DYG
Medtronic Vascular
Cardiovascular · 43d
Cleared Aug 28, 2001
WH ACCU TEST PREGNANCY TEST
K012284 · JHI
W.H.P.M., Inc.
Chemistry · 39d
Cleared Aug 28, 2001
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE...
K012431 · JJY
Bionostics, Inc.
Chemistry · 28d
Cleared Aug 27, 2001
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM,...
K002328 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 391d
Cleared Aug 27, 2001
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411 · FGE
Cordis Corp.
Gastroenterology & Urology · 196d
Cleared Aug 27, 2001
NEUROEDGE INFUSION CATHETER
K011646 · KRA
Neuro Vasx, Inc.
Cardiovascular · 90d
Cleared Aug 27, 2001
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K011657 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Aug 27, 2001
GPW-SF
K011659 · EJT
Gateway Alloys, Inc.
Dental · 90d
Cleared Aug 27, 2001
CONCORD 88
K011661 · EJT
Gateway Alloys, Inc.
Dental · 90d
Cleared Aug 27, 2001
MACROPORE IB RESORBABLE PLUG
K011715 · JDI
Macropore Biosurgery, Inc.
Orthopedic · 84d
Cleared Aug 27, 2001
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC...
K011886 · ODG
Olympus America, Inc.
Radiology · 73d
Cleared Aug 27, 2001
DIRECT BILIRUBIN REAGENT
K011972 · CIG
Intersect Systems, Inc.
Chemistry · 63d
Cleared Aug 27, 2001
DRI ECSTASY URINE CALIBRATORS
K012109 · DLJ
Microgenics Corp.
Toxicology · 52d