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
85033–85056 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1999
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
K984573 · LPN
Alcon Laboratories
Ophthalmic · 267d
Cleared Sep 16, 1999
ECHOFLOW DOPPLER BLOOD VELOCITY METER
K990642 · JOP
Echocath, Inc.
Cardiovascular · 202d
Cleared Sep 16, 1999
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)
K992143 · JWY
Pasco Laboratories, Inc.
Microbiology · 84d
Cleared Sep 16, 1999
BEAR CUB 750 PSV
K992788 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 28d
Cleared Sep 16, 1999
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
K992839 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 24d
Cleared Sep 16, 1999
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
K992892 · LNH
Magnetic Moments, LLC
Radiology · 20d
Cleared Sep 15, 1999
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
K983196 · DRO
Tz Medical, Inc.
Cardiovascular · 369d
Cleared Sep 15, 1999
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT...
K983232 · DRO
Tz Medical, Inc.
Cardiovascular · 366d
Cleared Sep 15, 1999
NUCLISENS CMV PP67
K983762 · LIN
Organon Teknika Corp.
Microbiology · 324d
Cleared Sep 15, 1999
REDI-TEST OPIATES
K991883 · DJG
Advantage Diagnostics Corp.
Toxicology · 105d
Cleared Sep 15, 1999
BOLUS ACCESSORY SET
K992072 · FPA
I-Flow Corp.
General Hospital · 88d
Cleared Sep 15, 1999
NAC PRN NEEDLELESS ACCESS CONNECTOR
K992268 · FPA
The Kipp Group
General Hospital · 71d
Cleared Sep 15, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K992399 · CIX
Bayer Corp.
Chemistry · 58d
Cleared Sep 15, 1999
CARESIDE CO2, TOTAL
K992475 · KHS
Careside, Inc.
Chemistry · 51d
Cleared Sep 15, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM,...
K992755 · FGE
Cordis, A Johnson & Johnson Co.
Gastroenterology & Urology · 30d
Cleared Sep 15, 1999
CYNOSURE ACCOLADE LASER
K992814 · GEX
Cynosure, Inc.
General & Plastic Surgery · 26d
Cleared Sep 15, 1999
CORDIS EXTREME PTA BALLOON CATHETER
K992825 · LIT
Cordis Corp.
Cardiovascular · 23d
Cleared Sep 15, 1999
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE...
K992910 · DTZ
Medtronic Vascular
Cardiovascular · 16d
Cleared Sep 14, 1999
HELICA TC
K972267 · GEI
Tenerco, Inc.
General & Plastic Surgery · 819d
Cleared Sep 14, 1999
HAMILTON MEDICAL GALILEOVENTILATOR
K982910 · CBK
Hamilton Medical, Inc.
Anesthesiology · 392d
Cleared Sep 14, 1999
HYDROFERA BACTERISTATIC NASAL DRESSING
K983276 · EMX
Hydrofera, LLC
Ear, Nose, Throat · 362d
Cleared Sep 14, 1999
LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
K990212 · DYX
Doctor'S Research Group, Inc.
Dental · 235d
Cleared Sep 14, 1999
DANEK PLATE AND SCREW SYSTEM
K991036 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 169d
Cleared Sep 14, 1999
MADTRONIC DLP ARTERIAL CANNULAE
K991066 · DWF
Medtronic Vascular
Cardiovascular · 167d