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
78553–78576 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2001
SUMMIT DUOFIX HIP PROSTHESIS
K011489 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Jul 31, 2001
RESORBABLE BONE PINS
K011522 · HTY
Biomet, Inc.
Orthopedic · 75d
Cleared Jul 31, 2001
QCU ANALYTICAL SOFTWARE PACKAGE
K011582 · LLZ
Medis Medical Imaging Systems BV
Radiology · 69d
Cleared Jul 31, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
K011658 · JIX
Rochdiag
Chemistry · 63d
Cleared Jul 31, 2001
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP...
K011672 · LAF
ACON Laboratories, Inc.
Toxicology · 62d
Cleared Jul 31, 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST...
K011673 · DKZ
ACON Laboratories, Inc.
Toxicology · 62d
Cleared Jul 31, 2001
BISTITE II DC
K011685 · EMA
Tokuyama America, Inc.
Dental · 61d
Cleared Jul 31, 2001
ZOLL M SERIES IBP OPERATION
K011865 · DSK
Zoll Medical Corp
Cardiovascular · 47d
Cleared Jul 31, 2001
GLUCOSE (HEXOKINASE)
K011900 · CFR
Jas Diagnostics, Inc.
Chemistry · 43d
Cleared Jul 31, 2001
POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K011995 · LYY
Quality Latex Products Malaysia Sdn Bhd
General Hospital · 35d
Cleared Jul 31, 2001
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
K012099 · LLZ
Totoku Electric Co., Ltd.
Radiology · 26d
Cleared Jul 31, 2001
PASS SPINAL SYSTEM
K012175 · MNI
Encore Orthopedics, Inc.
Orthopedic · 19d
Cleared Jul 31, 2001
EFILM WORKSTATION
K012211 · LLZ
Efilm Medical, Inc.
Radiology · 15d
Cleared Jul 31, 2001
SCALPFIX CLIP SYSTEM
K012219 · HBO
Aesculap, Inc.
General & Plastic Surgery · 15d
Cleared Jul 31, 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
K012251 · JWH
Exactech, Inc.
Orthopedic · 13d
Cleared Jul 30, 2001
BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
K010734 · MLK
Branan Medical Corp.
Chemistry · 140d
Cleared Jul 30, 2001
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
K011052 · JMM
Ostex Intl., Inc.
Chemistry · 115d
Cleared Jul 30, 2001
RADS
K011054 · DIO
Chason Healthcare, LLC
Toxicology · 115d
Cleared Jul 30, 2001
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353 · DJG
ACON Laboratories, Inc.
Toxicology · 88d
Cleared Jul 30, 2001
MITYVAC
K011532 · HDB
Prism Enterprises, Inc.
Obstetrics & Gynecology · 73d
Cleared Jul 30, 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
K011662 · DDG
The Binding Site, Ltd.
Immunology · 62d
Cleared Jul 30, 2001
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
K011663 · DEM
The Binding Site, Ltd.
Immunology · 62d
Cleared Jul 27, 2001
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL...
K002336 · IPF
Apex Medical Corp.
Physical Medicine · 360d
Cleared Jul 27, 2001
WELL-TENS
K002874 · GZJ
Well-Life Consultant
Neurology · 316d