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
81841–81864 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 31, 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 75d
Cleared Jul 31, 2000
PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
K001690 · FMI
Johnson & Johnson Medical, Inc.
General Hospital · 59d
Cleared Jul 31, 2000
DC TITAN
K001798 · EJH
Austenal, Inc.
Dental · 47d
Cleared Jul 31, 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
K001883 · HIS
Ansell Healthcare, Inc.
Obstetrics & Gynecology · 40d
Cleared Jul 31, 2000
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
K002101 · FGE
AngioDynamics, Inc.
Gastroenterology & Urology · 49d
Cleared Jul 31, 2000
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH...
K002175 · LYY
Sgmp Co., Ltd.
General Hospital · 12d
Cleared Jul 31, 2000
NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH...
K002176 · LYY
Sgmp Co., Ltd.
General Hospital · 12d
Cleared Jul 31, 2000
ADVANCED UROSCIENCE INJECTION NEEDLE
K002323 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 34d