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
74425–74448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2002
PSG INPUT BOX, MODEL JE-912AK
K022121 · OLV
Nihon Kohden America, Inc.
Neurology · 28d
Cleared Jul 29, 2002
BD VACUTAINER PLUS PST II TUBE
K022130 · JKA
Becton, Dickinson & CO
Chemistry · 28d
Cleared Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K022161 · GKZ
Beckman Coulter, Inc.
Hematology · 26d
Cleared Jul 29, 2002
MODIFICATION TO CARDEON AEGIS CATHETER
K022174 · DWF
Cardeon Corp.
Cardiovascular · 26d
Cleared Jul 29, 2002
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
K022200 · GKZ
Abx Diagnostics
Hematology · 24d
Cleared Jul 26, 2002
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
K011329 · BXQ
E. Benson Hood Lab, Inc.
Anesthesiology · 451d
Cleared Jul 26, 2002
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
K020882 · LZU
Surgical Specialties Corp
Ophthalmic · 130d
Cleared Jul 26, 2002
FOSSA URETERAL STONE SWEEPER
K021602 · FAD
Fossa Industries, Inc.
Gastroenterology & Urology · 72d
Cleared Jul 26, 2002
ILT ADVANCING MECHANISM, MODEL A115AMI
K021638 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 67d
Cleared Jul 26, 2002
XTD THROMBECTOMY CATHETER, XX CM
K021641 · QEW
Xtrak Medical, Inc.
Cardiovascular · 67d
Cleared Jul 26, 2002
CHROLOY SOLDER
K021965 · EJH
Neirynck & Vogt NV
Dental · 39d
Cleared Jul 26, 2002
CERALOY SOLDER
K021968 · EJH
Neirynck & Vogt NV
Dental · 39d
Cleared Jul 26, 2002
ELPH INJECTION SYSTEM
K022116 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 25d
Cleared Jul 26, 2002
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
K022164 · HKI
Zeta Development Laboratories
Ophthalmic · 23d
Cleared Jul 25, 2002
WU'S 3-WHEELED NEO SCOOTER, WT-M3
K014119 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 220d
Cleared Jul 25, 2002
MULTIGAS UNIT, MODEL AG-920RA
K020046 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 199d
Cleared Jul 25, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K021061 · KWP
Medtronic Sofamor Danek
Orthopedic · 114d
Cleared Jul 25, 2002
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2
K021316 · LBS
Genzyme Corp.
Chemistry · 91d
Cleared Jul 25, 2002
ORTHOPILOT HTO MODULE
K021327 · HAW
Aesculap, Inc.
Neurology · 90d
Cleared Jul 25, 2002
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
K021330 · MOS
Usa Instruments, Inc.
Radiology · 90d
Cleared Jul 25, 2002
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
K021336 · MQV
Novabone Products, LLC
Orthopedic · 90d
Cleared Jul 25, 2002
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
K021504 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 77d
Cleared Jul 25, 2002
K-ASSAY LP(A) ASSAY
K021660 · DFC
Kamiya Biomedical Co.
Chemistry · 66d
Cleared Jul 25, 2002
STAT PROFILE PHOX PLUS C ANALYZER
K021713 · CHL
Nova Biomedical Corp.
Chemistry · 63d