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
70489–70512 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2003
ADEPT 1064/532/755 LASER
K032218 · GEX
Adept Medical Concepts
General & Plastic Surgery · 95d
Cleared Oct 24, 2003
ADEPT 1064/532 LASER
K032220 · GEX
Adept Medical Concepts
General & Plastic Surgery · 95d
Cleared Oct 24, 2003
ADEPT 1064/755 LASER
K032221 · GEX
Adept Medical Concepts
General & Plastic Surgery · 95d
Cleared Oct 24, 2003
CAP BONE SUBSTITUTE MATERIAL
K032307 · GXP
Etex Corp.
Neurology · 91d
Cleared Oct 24, 2003
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
K032348 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 86d
Cleared Oct 24, 2003
QUANTEX D-DIMER
K032419 · DAP
Instrumentation Laboratory CO
Hematology · 80d
Cleared Oct 24, 2003
NASAL JACKS MASK
K032433 · BZD
Resmed, Ltd.
Anesthesiology · 79d
Cleared Oct 24, 2003
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482 · GKR
Stanbio Laboratory
Hematology · 73d
Cleared Oct 24, 2003
INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10
K032703 · GEX
Innovatech Surgical, Inc.
General & Plastic Surgery · 52d
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