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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
42985–43008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 2012
BIOPSY DIGIT S BIOPSY SL
K113607 · IZH
Giotto USA, LLC
Radiology · 248d
Cleared Aug 10, 2012
POWDER FREE LATEX EXAMINATION GLOVES
K113685 · LYY
Khai Hoan Joint Stock Company
General Hospital · 239d
Cleared Aug 10, 2012
WIRELESS IMAGE TRANSMITTER UNIT
K120278 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 193d
Cleared Aug 10, 2012
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY...
K120554 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 169d
Cleared Aug 10, 2012
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
K120715 · HSB
Zimmer GmbH
Orthopedic · 155d
Cleared Aug 10, 2012
ET/SS IMPLANT SYSTEM
K120847 · DZE
Osstem Implant Co., Ltd.
Dental · 143d
Cleared Aug 10, 2012
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
K121197 · DSI
Preventice, Inc.
Cardiovascular · 113d
Cleared Aug 10, 2012
C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
K121320 · ODP
Medyssey Co, Ltd.
Orthopedic · 100d
Cleared Aug 10, 2012
NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
K121368 · LZA
Matang Mfg. Sdn. Bhd.
General Hospital · 95d
Cleared Aug 10, 2012
LUBE JELLY SURINGE
K121390 · KMJ
Nurse Assist, Inc.
General Hospital · 93d
Cleared Aug 10, 2012
AIMAGO EASYLDI MICROCIRCULATION CAMERA
K121429 · DPT
Aimago SA
Cardiovascular · 88d
Cleared Aug 10, 2012
MULTIX FUSION
K121513 · KPR
Siemens Medical Solution
Radiology · 81d
Cleared Aug 10, 2012
COMFORT EZ
K121632 · FMI
Simple Diagnostics, Inc.
General Hospital · 67d
Cleared Aug 10, 2012
SCEPTER C OCCLUSION BALLOON CATHETER
K121785 · MJN
MicroVention, Inc.
Cardiovascular · 53d
Cleared Aug 10, 2012
IMRIS ONCOLOGY PACKAGE
K121997 · LNH
Imris, Inc.
Radiology · 32d
Cleared Aug 09, 2012
XENX
K113692 · OCY
Xenolith Medical
Gastroenterology & Urology · 238d
Cleared Aug 09, 2012
ESPIN
K120553 · HRX
Nlt Spine, Ltd.
Orthopedic · 168d
Cleared Aug 09, 2012
PICASSO MIS SPINAL FIXATION SYSTEM
K120714 · NKB
Accel Spine
Orthopedic · 154d
Cleared Aug 09, 2012
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
K120781 · DQY
Fuji Systems Corp.
Cardiovascular · 147d
Cleared Aug 09, 2012
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136 · KWP
Accel Spine
Orthopedic · 118d
Cleared Aug 09, 2012
CRAWFORD BIOCANALICULUS INTUBATION
K121142 · OKS
Fci Sas (France Chirurgie...
Ophthalmic · 115d
Cleared Aug 09, 2012
PROFEMUR Z REVISION HIP STEM
K121221 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 108d
Cleared Aug 09, 2012
INSIGNIA
K121524 · DYW
Ormco Corp.
Dental · 78d
Cleared Aug 08, 2012
CONICAL CONNECTION IMPLANTS
K112162 · DZE
Mis Implants Technologies , Ltd.
Dental · 378d