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
94465–94488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 21, 1997
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K964770 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 86d
Cleared Feb 21, 1997
DENTEMP ONE STEP
K964773 · EMA
Majestic Drug Co., Inc.
Dental · 86d
Cleared Feb 21, 1997
CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR
K964994 · CAF
Contemporary Products, Inc.
Anesthesiology · 67d
Cleared Feb 21, 1997
SPYGLASS ANGIOGRAPHIC CATHETER
K965249 · DQO
Daig Corp.
Cardiovascular · 71d
Cleared Feb 20, 1997
HEMAGEN CMV IGG KIT
K944438 · LFZ
Hemagen Diagnostics, Inc.
Microbiology · 892d
Cleared Feb 20, 1997
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K962475 · CAC
Transfusion Technologies Corp.
Anesthesiology · 240d
Cleared Feb 20, 1997
MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
K962517 · MNS
Healthdyne Technologies, Inc.
Anesthesiology · 238d
Cleared Feb 20, 1997
MAXI LD PTA BALLOON CATHETER
K963000 · LIT
Cordis Corp.
Cardiovascular · 202d
Cleared Feb 20, 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · LDJ
Drial Consultants, Inc.
Toxicology · 189d