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
36385–36408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 94d
Cleared Oct 03, 2014
Viberect Penile Vibratory Stimulation Device
K142304 · KXQ
Reflexonic, LLC
Obstetrics & Gynecology · 46d
Cleared Oct 03, 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · HWC
Zimmer, Inc.
Orthopedic · 31d
Cleared Oct 03, 2014
UGEO PT60A Diagnostic Ultrasound System
K142466 · IYN
Samsung Medison Co., Ltd.
Radiology · 31d
Cleared Oct 03, 2014
HyProCure II
K142534 · HWC
Graham Medical Technologies, LLC Dba...
Orthopedic · 24d
Cleared Oct 03, 2014
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
K142536 · PGY
Jvckenwood Corporation
Radiology · 24d
Cleared Oct 03, 2014
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
K142540 · PGY
Jvckenwood Corporation
Radiology · 24d
Cleared Oct 02, 2014
Electro Auricular Device
K140530 · BWK
Navigant Consulting, Inc.
Neurology · 212d
Cleared Oct 02, 2014
JUGGERKNOT MINI SOFT ANCHOR
K140908 · DZL
Biomet Sports Medicine
Dental · 176d
Cleared Oct 02, 2014
PADI-LOCK
K141200 · FPA
Padi-Lock, LLC
General Hospital · 146d
Cleared Oct 02, 2014
EMERGE MEDICAL IM NAIL SYSTEM
K141347 · HSB
Emerge Medical
Orthopedic · 133d
Cleared Oct 02, 2014
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
K141542 · DQA
Covidien, LLC
Anesthesiology · 114d
Cleared Oct 02, 2014
SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION
K141664 · MEG
Rexam Healthcare
General Hospital · 101d
Cleared Oct 02, 2014
Varian Verification System (VVS)
K142268 · IYE
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Oct 02, 2014
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System,...
K142302 · CGA
Polymer Technology Systems, Inc.
Chemistry · 45d
Cleared Oct 01, 2014
INNESIS PEEK TL CAGE
K140577 · MAX
Bk Meditech, Co., Ltd.
Orthopedic · 209d
Cleared Oct 01, 2014
Barrx RFA Self Sizing Balloon Catheter
K142364 · GEI
Covidien, LLC
General & Plastic Surgery · 37d
Cleared Oct 01, 2014
DIVERGENCE Anterior Cervical Fusion System
K142450 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Oct 01, 2014
EXPEDIUM Spine System/Synapse System
K142460 · KWP
Johnson and Johnson
Orthopedic · 29d
Cleared Sep 30, 2014
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL...
K130450 · KGO
Purna Bina Sdn Bhd
General Hospital · 585d
Cleared Sep 30, 2014
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT),...
K140371 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 228d
Cleared Sep 30, 2014
COMP A-I-R
K141140 · CAF
Omron Healthcare, Inc.
Anesthesiology · 151d
Cleared Sep 30, 2014
AER-O-SCOPE COLONOSCOPE SYSTEM
K141286 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 137d
Cleared Sep 30, 2014
PROFLUORO FLUORIDE VARNISH
K141422 · LBH
Pac-Dent International, Inc.
Dental · 123d