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
82465–82488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 2000
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
K993923 · MUJ
Adac Laboratories
Radiology · 141d
Cleared Apr 07, 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
K994165 · DIO
Roche Diagnostics Corp.
Toxicology · 120d
Cleared Apr 06, 2000
JELDENT BASIC LINE
K000213 · ELM
J.F. Jelenko & Co.
Dental · 73d
Cleared Apr 06, 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461 · LDJ
Dade Behring, Inc.
Toxicology · 55d
Cleared Apr 06, 2000
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
K000462 · LCM
Dade Behring, Inc.
Toxicology · 55d
Cleared Apr 06, 2000
JEL 15
K000532 · EJS
J.F. Jelenko & Co., Inc.
Dental · 49d
Cleared Apr 06, 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · HIS
Armkel, LLC
Obstetrics & Gynecology · 29d
Cleared Apr 06, 2000
CORDIS 13F CATHETER SHEATH INTRODUCER
K000753 · DRF
Cordis Corp.
Cardiovascular · 29d
Cleared Apr 06, 2000
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051
K000763 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 28d
Cleared Apr 06, 2000
PEDIATRIC FIXATION RODS
K000764 · JDS
Biomet, Inc.
Orthopedic · 28d
Cleared Apr 06, 2000
AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT...
K000822 · DSI
Agilent Technologies, GmbH
Cardiovascular · 23d
Cleared Apr 06, 2000
STERLTECH WATER PURIFIER
K000941 · EIA
Sterltech, Inc.
Dental · 14d
Cleared Apr 06, 2000
LEVEEN NEEDLE ELECTRODE
K982556 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 624d
Cleared Apr 06, 2000
OSTEONICS SERIES 7000 AD TIBIAL TRAY
K983657 · HRY
Osteonics Corp.
Orthopedic · 535d
Cleared Apr 06, 2000
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
K991060 · DRF
Zcv ,Inc.
Cardiovascular · 373d
Cleared Apr 06, 2000
BICON-PLUS ACETABULAR COMPONENTS
K992154 · LPH
Plus Orthopedics
Orthopedic · 286d
Cleared Apr 06, 2000
ESKA MODULAR HIP SYSTEM
K993027 · LPH
Specs USA, Inc.
Orthopedic · 210d
Cleared Apr 05, 2000
ACTICOAT FOAM DRESSING
K000051 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 89d
Cleared Apr 05, 2000
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
K000235 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 69d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
K000330 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
RANDOX CALCIUM
K000375 · CIC
Randox Laboratories, Ltd.
Chemistry · 58d
Cleared Apr 05, 2000
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
K000466 · DJR
Dade Behring, Inc.
Toxicology · 54d