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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69289–69312 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2003
MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
K032841 · DPT
Moor Instruments, Ltd.
Cardiovascular · 90d
Cleared Dec 10, 2003
STRYKER SPINE MAPS SYSTEM
K032855 · MNH
Howmedica Osteonics
Orthopedic · 89d
Cleared Dec 10, 2003
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT
K032953 · KLE
Pulpdent Corporation
Dental · 79d
Cleared Dec 10, 2003
TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700
K033025 · DXN
Tytan Medical Corp.
Cardiovascular · 75d
Cleared Dec 10, 2003
C-GRAFT
K033110 · LYC
The Clinician'S Preference, LLC
Dental · 71d
Cleared Dec 10, 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269 · OCW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 62d
Cleared Dec 10, 2003
IMMEDIATE STABILIZING IMPLANT (ISI)
K033392 · DZE
"O" Co., Inc.
Dental · 48d
Cleared Dec 10, 2003
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006,...
K033537 · FGE
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Dec 10, 2003
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
K033544 · IPF
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 30d
Cleared Dec 10, 2003
MODIFICATION TO AURORA DS
K033586 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 27d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · HRS
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Dec 09, 2003
REDLINE ANTHRAX ALERT TEST
K030370 · NPO
Tetracore, Inc.
Microbiology · 308d
Cleared Dec 09, 2003
CD LEYCOM PRESSURE/VOLUME CATHETERS
K031599 · DQO
Cd Leycom BV
Cardiovascular · 202d
Cleared Dec 09, 2003
SPIROTEL, MODEL 29-1020
K031643 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 196d
Cleared Dec 09, 2003
MONA LISA ASPIRATION NEEDLE
K032208 · MQE
Fertility Technology Resources, Inc.
Obstetrics & Gynecology · 144d
Cleared Dec 09, 2003
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K032690 · LFL
Misonix, Inc.
General & Plastic Surgery · 98d
Cleared Dec 09, 2003
OB1 OBSTETRICAL DOPPLER
K033156 · KNG
D. E. Hokanson, Inc.
Radiology · 70d
Cleared Dec 09, 2003
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
K033184 · IZI
Shimadzu Corp.
Radiology · 69d
Cleared Dec 09, 2003
ALLURA XPER FD20
K033737 · OWB
Philips Medical Systems North...
Radiology · 11d
Cleared Dec 08, 2003
AUTOGEL PAD
K031018 · MUI
Rich-Mar Corp.
Radiology · 252d
Cleared Dec 08, 2003
FLUID FILLED TEETHERS
K031094 · KKO
Royal King Infant Products Co. , Ltd.
Dental · 245d
Cleared Dec 08, 2003
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
K032812 · MQP
Orthovita, Inc.
Orthopedic · 90d
Cleared Dec 08, 2003
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
K032827 · KSR
Tyco Healthcare
Hematology · 89d
Cleared Dec 08, 2003
ACRA-CUT XPRESS 120
K032970 · HBF
Acra Cut, Inc.
Neurology · 76d