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
98281–98304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1996
CALIBRATION VERIFICATION ASSESSMENT (CVA)
K960557 · JPK
Streck Laboratories, Inc.
Hematology · 54d
Cleared Apr 03, 1996
PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED...
K960635 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Apr 03, 1996
TYMPANOSTOMY VENTILATION TUBE
K960742 · ETD
Advanced Microbotics Corp.
Ear, Nose, Throat · 40d
Cleared Apr 03, 1996
ACE SYSTEM
K960853 · EQJ
Xomed, Inc.
Ear, Nose, Throat · 33d
Cleared Apr 03, 1996
LIPID CONTROL
K960862 · JJY
Medical Analysis Systems, Inc.
Chemistry · 33d
Cleared Apr 03, 1996
AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL,...
K960935 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 03, 1996
STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K960997 · LIO
Starplex Scientific, Inc.
Microbiology · 22d
Cleared Apr 03, 1996
XRE COLLIMATOR
K960998 · IZW
Xre Corp.
Radiology · 22d
Cleared Apr 02, 1996
SAFE TEE
K955076 · GCJ
Pearson Strach Medical
General Hospital · 153d
Cleared Apr 02, 1996
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444 · LAR
Abbott Laboratories
Toxicology · 126d
Cleared Apr 02, 1996
SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE
K960046 · HRX
Surgical Dynamics, Inc.
Orthopedic · 91d
Cleared Apr 02, 1996
NUMED ATRIOSEPTOSTOMY CATHETER
K960070 · DQO
NuMED, Inc.
Cardiovascular · 88d
Cleared Apr 02, 1996
COCAINE METABOLITE EIA TEST
K960187 · DIO
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Apr 02, 1996
SILGEL TOPICAL GEL SHEET
K960254 · MDA
Rofil Medical USA, Inc.
General & Plastic Surgery · 76d
Cleared Apr 02, 1996
PPV VAPORIZER (MODIFICATION)
K960944 · CAD
Penlon , Ltd.
Anesthesiology · 49d
Cleared Apr 02, 1996
1-4F INFINITI ANGIOGRAPHIC CATHETER
K960975 · DQO
Cordis Corp.
Cardiovascular · 22d
Cleared Apr 01, 1996
CONSENSUS ALL POLY TIBIA
K952943 · JWH
U.S. Medical Products, Inc.
Orthopedic · 280d
Cleared Apr 01, 1996
SHADOW MEDAL LOCATOR
K953277 · HPM
Fatswith Intl., Inc.
Ophthalmic · 263d
Cleared Apr 01, 1996
BANKS HYDRO-THERAPY CHAIR
K953796 · ILM
Keith Products, Inc.
Physical Medicine · 231d
Cleared Apr 01, 1996
MATRIX MICROSON 410
K954136 · IMI
Matrix Biokinetics, Inc.
Physical Medicine · 213d
Cleared Apr 01, 1996
3I STANDARD THREADED IMPLANT
K954347 · DZE
Implant Innovations, Inc.
Dental · 196d
Cleared Apr 01, 1996
THE FREEDOM BED
K954671 · IKZ
Probed Medical Technologies, Inc.
Physical Medicine · 174d
Cleared Apr 01, 1996
ACE HUMERUS & RADIUS PLATES
K955472 · HRS
Ace Medical Co.
Orthopedic · 123d
Cleared Apr 01, 1996
SOLO BAND LIGATOR
K960020 · FHN
Surcraft, LLC
Gastroenterology & Urology · 90d