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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
91993–92016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1997
MICRO21 WITH CEREBROSPINAL FLUID
K971470 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 147d
Cleared Sep 16, 1997
DRAGER-VAPOR 2000
K971923 · CAD
Draeger Medical, Inc.
Anesthesiology · 116d
Cleared Sep 16, 1997
THE MAESTRO SYSTEM
K972313 · DZE
BioHorizons Implant Systems, Inc.
Dental · 88d
Cleared Sep 16, 1997
ABBOTT CELL-DYN 3200 SYSTEM
K972354 · GKZ
Abbott Laboratories
Hematology · 84d
Cleared Sep 16, 1997
STEALTHSTATION PASSIVE INSTRUMENT OPTION
K972398 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 82d
Cleared Sep 16, 1997
LIQCRYLIC PRO DENTAL RESIN
K972573 · EBI
Dentsply Intl.
Dental · 68d
Cleared Sep 16, 1997
ENLIGHT (TENTATIVE NAME)
K972890 · DYH
Sybron Dental Specialties, Inc.
Dental · 42d
Cleared Sep 16, 1997
AURECAST 92
K972943 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 88d
Cleared Sep 15, 1997
AXSYM CA 15-3
K963926 · MOI
Abbott Laboratories
Immunology · 350d
Cleared Sep 15, 1997
AUXILIARY INSTRUMENTS FOR URS
K971315 · FCL
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 159d
Cleared Sep 15, 1997
RIVETTI-LEVINSON INSTRALUMINAL SHUNT
K972261 · DWF
Integra Neurocare, LLC
Cardiovascular · 90d
Cleared Sep 15, 1997
FIRST PICC CATHETER
K972262 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 90d
Cleared Sep 15, 1997
FIRST PICC CATHETER WITH DUAL LUMENS
K972263 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 90d
Cleared Sep 15, 1997
FIRST MIDCATH CATHETER
K972264 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 90d
Cleared Sep 15, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972296 · MOS
Ge Medical Systems, Inc.
Radiology · 88d
Cleared Sep 15, 1997
SIEMENS ORTHOPHOS DS/DS CEPH
K972312 · EHD
Siemens AG
Radiology · 87d
Cleared Sep 15, 1997
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K972592 · MOS
Elscint, Inc.
Radiology · 66d
Cleared Sep 15, 1997
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
K973044 · LZG
Disetronic Medical Systems
General Hospital · 31d
Cleared Sep 12, 1997
TELE TRENS TM 10
K960884 · DSI
Life Sensing Instrument Company, Inc.
Cardiovascular · 557d
Cleared Sep 12, 1997
BABY DOPPLEX (3000)
K963711 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 361d
Cleared Sep 12, 1997
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
K970544 · KYJ
Depuy, Inc.
Orthopedic · 212d
Cleared Sep 12, 1997
FLOW-RITE
K971594 · EBF
Pulpdent Corp.
Dental · 134d
Cleared Sep 12, 1997
DCI WATER PURIFIER
K971727 · EIA
Dental Components, Inc.
Dental · 126d
Cleared Sep 12, 1997
BELLEGLASS HP ENAMEL REPAIR MATERIAL
K971762 · EBF
Sybron Dental Specialties, Inc.
Dental · 122d