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
84889–84912 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1999
GLUMA COMFORT BOND + DESENSITIZER
K992292 · KLE
Heraeus Kulzer, Inc.
Dental · 86d
Cleared Oct 01, 1999
AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION
K992317 · KPS
Adac Laboratories
Radiology · 84d
Cleared Oct 01, 1999
BECTON DICKINSON SYRINGE
K992734 · MEG
Bd Becton Dickinson Vacutainer...
General Hospital · 49d
Cleared Oct 01, 1999
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...
K992775 · KGI
Hologic, Inc.
Radiology · 44d
Cleared Oct 01, 1999
ADVANTA GRAFT (<6MM)
K992958 · DYF
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Oct 01, 1999
ADVANTA GRAFT (>6MM)
K992960 · DSY
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Oct 01, 1999
SILHOUETTE FC
K993090 · KPR
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Sep 30, 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
K990992 · LCP
Roche Diagnostics Corp.
Chemistry · 190d
Cleared Sep 29, 1999
DENZIR
K984201 · EIH
Dentronic AB
Dental · 309d
Cleared Sep 29, 1999
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F
K984415 · KOJ
S.S. White Technologies, Inc.
Dental · 293d
Cleared Sep 29, 1999
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
K991540 · LIT
AngioDynamics, Inc.
Cardiovascular · 149d
Cleared Sep 29, 1999
3I CERAMIC ABUTMENT SYSTEM
K991947 · DZE
Implant Innovations, Inc.
Dental · 112d
Cleared Sep 29, 1999
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
K992079 · JOW
The Kendall Company, L.P.
Cardiovascular · 100d
Cleared Sep 29, 1999
OLYMPUS WORKING ELEMENT FOR PROBES
K992141 · FDC
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 97d
Cleared Sep 29, 1999
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
K992352 · LMD
Inteleradiology, Inc.
Radiology · 77d
Cleared Sep 29, 1999
DIAGNOSTIC ULTRASOUND, MODEL 1.0
K992378 · IYO
Volumetrics Medical Imaging, Inc.
Radiology · 75d
Cleared Sep 29, 1999
INTRAMAX ITI GUIDE CATHETER
K992622 · DQY
Intratherapeutics, Inc.
Cardiovascular · 55d
Cleared Sep 29, 1999
SPRING POWERLITE 2000
K992728 · EBZ
Spring Health Products, Inc.
Dental · 47d
Cleared Sep 29, 1999
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
K992736 · HIB
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 47d
Cleared Sep 29, 1999
CARTO EP NAVIGATION SYSTEM
K992968 · DQK
Biosense Webster, Inc.
Cardiovascular · 26d
Cleared Sep 28, 1999
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE...
K990500 · EZL
The Kendal Co.
Gastroenterology & Urology · 223d
Cleared Sep 28, 1999
ORTHOPANTOMOGRAPH OP100D
K992385 · MUH
Instrumentarium Corp.
Radiology · 74d
Cleared Sep 28, 1999
ELECSYS PARATHYROID HORMONE TEST SYSTEM
K992680 · CEW
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P,...
K992798 · CDO
Sigma Diagnostics, Inc.
Chemistry · 40d