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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94969–94992 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1997
ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
K962827 · DSI
Marquette Electronics, Inc.
Cardiovascular · 220d
Cleared Feb 24, 1997
CARETONE II
K963678 · DQD
American Telecare, Inc.
Cardiovascular · 164d
Cleared Feb 24, 1997
MITEK ABSORBABLE TOGGLE ANCHOR
K964013 · MAI
Mitek Products
Orthopedic · 140d
Cleared Feb 24, 1997
KINEMATIC POSITIONING DEVICES
K964752 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 89d
Cleared Feb 24, 1997
HI-STAR MRI IMAGING SYSTEM
K964778 · LNH
Health Images, Inc.
Radiology · 89d
Cleared Feb 24, 1997
INNOVASIVE DEVICES ROTATOR CUFF FASTNER
K964945 · MBI
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Feb 24, 1997
KINEMAX PLUS TIBIAL SPACERS
K964951 · JWH
Howmedica Corp.
Orthopedic · 76d
Cleared Feb 24, 1997
INTERMITTENT COMPRESSOR SYSTEM
K964957 · IRP
Eischoco, Inc.
Physical Medicine · 75d
Cleared Feb 24, 1997
COHORT DISCECTOMY SYSTEMS (CDS)
K964975 · HRX
Cohort Medical Products Group, Inc.
Orthopedic · 74d
Cleared Feb 24, 1997
IAMIN IMPREGNATED GAUZE DRESSING
K965005 · MGQ
Procyte Corp.
General & Plastic Surgery · 70d
Cleared Feb 21, 1997
CHARTR EP
K960097 · GWJ
Ics Medical Corp.
Neurology · 407d
Cleared Feb 21, 1997
TRI-FLOW THREE WAY STOPCOCK
K961982 · FMG
North, Inc.
General Hospital · 277d
Cleared Feb 21, 1997
VASOTHERM
K962243 · IMJ
Ehti Medical Corp.
Physical Medicine · 255d
Cleared Feb 21, 1997
THEE THERMASTIM
K962703 · IMJ
Ehti Medical Corp.
Physical Medicine · 224d
Cleared Feb 21, 1997
CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS)...
K962765 · DQX
Cordis Corp.
Cardiovascular · 220d
Cleared Feb 21, 1997
TUM-E-VAC
K962850 · KDH
Ethox Corp.
Gastroenterology & Urology · 214d
Cleared Feb 21, 1997
9000 SERIES FILTER & FILTER/HME
K963053 · CAH
Enternet Medical, Inc.
General Hospital · 199d
Cleared Feb 21, 1997
INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL...
K963081 · GEX
Indigo Medical, Inc.
General & Plastic Surgery · 197d
Cleared Feb 21, 1997
FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)
K964055 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 135d
Cleared Feb 21, 1997
RHEO DOPPLEX II (RD 2)
K964699 · IYN
Huntleigh Technology, Inc.
Radiology · 88d
Cleared Feb 21, 1997
PRISM XPVT SYSTEM (210823)
K964712 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 21, 1997
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
K964719 · BTM
Hudson Respiratory Care, Inc.
Anesthesiology · 88d
Cleared Feb 21, 1997
EAGLE 4000 PATIENT MONITOR
K964750 · LOS
Marquette Electronics, Inc.
Cardiovascular · 87d
Cleared Feb 21, 1997
CERALAS DIODE LASER SYSTEM (CERALAS D2)
K964751 · HQF
Ceram Optec, Inc.
Ophthalmic · 87d