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
36601–36624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2014
MOSAIQ ONCOLOGY INFORMATION SYSTEM
K141572 · IYE
Impac Medical Systems, Inc.
Radiology · 85d
Cleared Sep 05, 2014
ARTIS ZEE/ZEEGO SW VC21
K141574 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Sep 05, 2014
MASTERGRAFT MATRIX EXT
K141824 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 60d
Cleared Sep 05, 2014
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE...
K142035 · NBW
Arkray Factory, Inc.
Chemistry · 39d
Cleared Sep 05, 2014
ELI 380 ELECTROCARDIOGRAPH
K142105 · DPS
Mortara Instrument, Inc.
Cardiovascular · 35d
Cleared Sep 05, 2014
ELECSYS ESTRADIOL III CALCHECK 5
K142127 · JJX
Roche Diagnostics
Chemistry · 32d
Cleared Sep 05, 2014
PALACOS R+G PRO
K142157 · LOD
Heraeus Medical GmbH
Orthopedic · 30d
Cleared Sep 04, 2014
QMASTER-H/REVO
K133797 · OAS
Telesystems Co., Ltd.
Radiology · 265d
Cleared Sep 04, 2014
PREMIUM
K133889 · FTL
Cousin Biotech Sas
General & Plastic Surgery · 258d
Cleared Sep 04, 2014
RHINIX NASAL FILTER
K134003 · NUP
Rhinix Aps
Ear, Nose, Throat · 251d
Cleared Sep 04, 2014
BIOMET GRAFT DELIVERY SYRINGES
K140710 · FMF
Biomet Spine (Aka Ebi, LLC)
General Hospital · 167d
Cleared Sep 04, 2014
COMPAT ENTERAL DELIVERY PUMP SETS
K140947 · PIF
Nestle Healthcare Nutrition, Inc.
Gastroenterology & Urology · 143d
Cleared Sep 04, 2014
CALCULASE II
K140964 · GEX
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 142d
Cleared Sep 04, 2014
FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM...
K141272 · GCJ
Minimmally Invasive Devices
General & Plastic Surgery · 112d
Cleared Sep 04, 2014
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · KNW
Stryker Corporation
Gastroenterology & Urology · 73d
Cleared Sep 04, 2014
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 71d
Cleared Sep 04, 2014
HYDRAVIEW GUIDEWIRE
K141831 · DQX
Brivant Limited
Cardiovascular · 59d
Cleared Sep 04, 2014
HFD100 ROCKER ARM ACCESSORY
K141950 · HBL
Imris, Inc.
Neurology · 48d
Cleared Sep 03, 2014
ALERE PBP2A SA/CONS CULTURE COLONY TEST
K133851 · MYI
Alere Scarborough, Inc.
Microbiology · 258d
Cleared Sep 03, 2014
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM
K133911 · KWQ
Genesys Spine
Orthopedic · 254d
Cleared Sep 03, 2014
GENERAL SPINAL SYSTEM
K134011 · MNH
Changzhou Dean Medical Instrument Co,...
Orthopedic · 247d
Cleared Sep 03, 2014
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K140418 · LZA
Wrp Rubber Products Sdn Bhd
General Hospital · 197d
Cleared Sep 03, 2014
XENCO MEDICAL CERVICAL INTERBODY SYSTEM
K140786 · ODP
Xenco Medical, LLC
Orthopedic · 156d
Cleared Sep 03, 2014
VDRIVE WITH V-LOOP/ VDRIVE DUO
K140804 · DXX
Stereotaxis, Inc.
Cardiovascular · 156d