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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
140569–140592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1987
SUPER PLUS TAMPONS
K864652 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 98d
Cleared Mar 04, 1987
VISTA INTERFACE SYSTEM
K864852 · BZL
Vacumetrics, Inc.
Anesthesiology · 83d
Cleared Mar 04, 1987
SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS
K864859 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 83d
Cleared Mar 04, 1987
'EXMOOR' ATKINS NASAL SPLINT
K864930 · EPP
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 78d
Cleared Mar 04, 1987
'EXMOOR' CAWOOD NASAL SPLINTS
K864932 · EPP
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 78d
Cleared Mar 04, 1987
'EXMOOR' SHAH & MACKAY NASAL SPLINTS
K864933 · EPP
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 78d
Cleared Mar 04, 1987
YSI MODEL 801
K865012 · FMT
Yellow Springs Instrument Co., Inc.
General Hospital · 71d
Cleared Mar 04, 1987
GDC 1824
K865049 · EJT
Deringer-Ney, Inc.
Dental · 70d
Cleared Mar 04, 1987
CHIRO-STIM
K865070 · IPF
Diversified Chiropractic Systems
Physical Medicine · 65d
Cleared Mar 04, 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Mar 04, 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Mar 04, 1987
THE EQUALIZER AIRWAY DEVICE
K870501 · LQZ
Sleep Renewal, Inc.
Dental · 28d
Cleared Mar 04, 1987
TEFLON UTERINE SOUND
K870550 · HHM
Cook Ob/Gyn
Obstetrics & Gynecology · 22d
Cleared Mar 04, 1987
COSMEDTECH CANNULA
K870560 · HHI
Cosmedtech, Inc.
Obstetrics & Gynecology · 22d
Cleared Mar 04, 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Mar 04, 1987
D. FARINAE ALLERGEN DISC
K870597 · DHB
Incstar Corp.
Immunology · 21d
Cleared Mar 04, 1987
HUNTLEIGH BETA II HM85
K870681 · FNM
Huntleigh Technology, Inc.
General Hospital · 13d
Cleared Mar 04, 1987
SMALL MASTOID RETRACTOR
K870758 · KAL
Treace Medical, Inc.
Ear, Nose, Throat · 6d
Cleared Mar 03, 1987
DUAL PHOTON BONE DENSITOMETER
K861233 · KGI
Medical and Scientific Enterprises, Inc.
Radiology · 336d
Cleared Mar 03, 1987
SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER
K863342 · DWF
Angiomedics, Inc.
Cardiovascular · 187d
Cleared Mar 03, 1987
HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM
K863783 · OLT
Hzi Research Center
Neurology · 158d
Cleared Mar 03, 1987
PLURIMUS CARDIAC EVALUATION SYSTEM
K864401 · DSI
Vivix Corp.
Cardiovascular · 117d
Cleared Mar 03, 1987
FRESENIUS ULTRAFLUX AV400, AV600
K864587 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 102d
Cleared Mar 03, 1987
ETP 300 NON-INVASIVE EXTERNAL PACEMAKER
K864986 · DRO
Medac, Inc.
Cardiovascular · 71d