Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82441–82464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2000
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
K001409 · CBF
Hyperbaric Technologies, Inc.
Anesthesiology · 90d
Cleared Aug 02, 2000
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
K001555 · HHK
Sims Portex , Ltd.
Obstetrics & Gynecology · 76d
Cleared Aug 02, 2000
DND 101
K001590 · KNA
Urogyn , Ltd.
Obstetrics & Gynecology · 77d
Cleared Aug 02, 2000
CHASE CARDIOVASCULAR PATCH
K001662 · DXZ
Chase Medical, Inc.
Cardiovascular · 63d
Cleared Aug 02, 2000
GALEO HYDRO AND GALEO HYDRO J-TIP
K001736 · DQX
Biotronik, Inc.
Cardiovascular · 56d
Cleared Aug 02, 2000
STANDARD IMAGING HDR 1000 PLUS ION CHAMBER
K001825 · JAQ
Standard Imaging, Inc.
Radiology · 47d
Cleared Aug 02, 2000
SIGMA
K001928 · MUH
Instrumentarium Imaging, Inc.
Radiology · 37d
Cleared Aug 02, 2000
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K002009 · MWI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Aug 02, 2000
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100 · GXZ
Te ME NA S.A.R.L.
Neurology · 576d
Cleared Aug 02, 2000
WATER FOR TISSUE CULTURE, MODELS 1500
K993140 · MTW
Conception Technologies
Obstetrics & Gynecology · 317d
Cleared Aug 01, 2000
WIN-1 TANGO
K000204 · ITI
Duracare Medical Equipment, L.C.
Physical Medicine · 193d
Cleared Aug 01, 2000
COAXIAL DILATOR SET
K000737 · DRE
Xentek Medical, Inc.
Cardiovascular · 147d
Cleared Aug 01, 2000
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1
K001182 · DXN
Microlife Corp.
Cardiovascular · 112d
Cleared Aug 01, 2000
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM
K001400 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Aug 01, 2000
PHORESOR MODEL PM2000
K001410 · KTB
Iomed, Inc.
Physical Medicine · 89d
Cleared Aug 01, 2000
DA VINCHI EMG/EP ISA1004EP
K001467 · GWE
Airsep Corp.
Neurology · 83d
Cleared Aug 01, 2000
A.V. FISTULA NEEDLE
K001496 · FIE
Exelint International, Co.
Gastroenterology & Urology · 78d
Cleared Aug 01, 2000
ULTRASOUND SCANNER, TYPE 1101
K002085 · IYO
B & K Medical A/S
Radiology · 22d
Cleared Aug 01, 2000
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K002185 · IYN
Medison America, Inc.
Radiology · 13d
Cleared Aug 01, 2000
EXPLORER CVS TRANSCRANIAL DOPPLER
K990517 · IYN
Diagnostic Medical Systems
Radiology · 530d
Cleared Aug 01, 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
K992905 · JEY
Codman & Shurtleff, Inc.
Dental · 337d
Cleared Aug 01, 2000
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS
K993524 · FRN
Alaris Medical Systems, Inc.
General Hospital · 288d
Cleared Jul 31, 2000
PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
K001515 · KPI
The Prometheus Group
Gastroenterology & Urology · 76d
Cleared Jul 31, 2000
SURGIFLATOR-40
K001533 · HIF
W.O.M. Gmhb
Obstetrics & Gynecology · 75d