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
69985–70008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2003
INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30
K032704 · GEX
Innovatech Surgical, Inc.
General & Plastic Surgery · 52d
Cleared Oct 24, 2003
MODIFICATION TO SUTURE CLINCH
K033024 · FZP
Applied Medical Resources Corp.
General & Plastic Surgery · 28d
Cleared Oct 24, 2003
CZR PRESS
K033049 · EIH
Noritake Co., Inc.
Dental · 25d
Cleared Oct 24, 2003
DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205
K033069 · FLL
Tenghi Co., Ltd.
General Hospital · 25d
Cleared Oct 24, 2003
SPR SYSTEM
K033181 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 23d
Cleared Oct 23, 2003
FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1
K023723 · DXN
Fms, Finapres Medical Systems BV
Cardiovascular · 352d
Cleared Oct 23, 2003
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
K030421 · NCX
Alsius Corp.
Neurology · 255d
Cleared Oct 23, 2003
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
K030627 · DRF
C.R. Bard, Inc.
Cardiovascular · 238d
Cleared Oct 23, 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · LZG
Medtronic Minimed
General Hospital · 100d
Cleared Oct 23, 2003
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
K032530 · FGE
Guidant Corporation
Gastroenterology & Urology · 69d
Cleared Oct 23, 2003
BIOPSY BREAST COIL, MODEL BBC
K032576 · MOS
Mri Devices Corp.
Radiology · 64d
Cleared Oct 23, 2003
COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
K032698 · GAM
Coapt Systems, Inc.
General & Plastic Surgery · 51d
Cleared Oct 23, 2003
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
K032820 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 43d
Cleared Oct 23, 2003
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K032930 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 31d
Cleared Oct 23, 2003
ELEKTA SYNERGY SYSTEM
K032996 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 28d
Cleared Oct 23, 2003
GE MARLIN ULTRASOUND
K033139 · IYN
General Electric Co.
Radiology · 23d
Cleared Oct 22, 2003
RAPHAEL
K022679 · CBK
Hamilton Medical AG
Anesthesiology · 436d
Cleared Oct 22, 2003
ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE
K023139 · KGO
Van Oostveen Medical B.V.
General Hospital · 397d
Cleared Oct 22, 2003
FERRIS POLYMEM SILVER WOUND DRESSING
K031307 · FRO
Ferris Mfg. Corp.
General & Plastic Surgery · 181d
Cleared Oct 22, 2003
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE...
K031329 · IMI
Dynatronics Corp.
Physical Medicine · 177d
Cleared Oct 22, 2003
CONKLUSION PEDICLE SCREW SYSTEM
K031455 · MNI
Signus Medical, LLC
Orthopedic · 168d
Cleared Oct 22, 2003
INTER-OS LIMB LENGTHENER
K031875 · KTT
Inter-Os Technologies
Orthopedic · 127d
Cleared Oct 22, 2003
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
K031952 · NOP
Focus Technologies, Inc.
Microbiology · 119d
Cleared Oct 22, 2003
WEST NILE VIRUS ELISA IGG, MODEL EL0300G
K031953 · NOP
Focus Technologies, Inc.
Microbiology · 119d