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
82969–82992 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 2000
HARDYDISK OFLOXACIN 5MCG
K000525 · JTN
Hardy Diagnostics
Microbiology · 51d
Cleared Apr 07, 2000
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
K000527 · GIR
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Apr 07, 2000
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
K000528 · GIR
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Apr 07, 2000
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
K000746 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 30d
Cleared Apr 07, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
K000828 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 24d
Cleared Apr 07, 2000
MDI SCL-70 TEST
K000934 · LJM
Micro Detect, Inc.
Immunology · 15d
Cleared Apr 07, 2000
KFA-63 KNEE AND FOOT ARRAY
K000935 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Apr 07, 2000
SIPHONGUARD CSF CONTROL DEVICE
K992173 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 284d
Cleared Apr 07, 2000
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
K993414 · DPS
Prucka Engineering, Inc.
Cardiovascular · 178d
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