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
139849–139872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1987
DROP MATE
K871326
Mtr Enterprises, Ltd.
Ophthalmic · 24d
Cleared Apr 27, 1987
BLOOD VESSEL CONNECTOR
K871408
Quali-Med, Inc.
Cardiovascular · 19d
Cleared Apr 24, 1987
SURE DROP
K870905
Sheldon Eyedrop Support, Inc.
Ophthalmic · 50d
Cleared Apr 23, 1987
BIOJECTOR SYRINGE SYSTEM
K861687 · KZE
Bioject, Inc.
General Hospital · 356d
Cleared Apr 23, 1987
CARERITE & COST RITE NYLON STERILIZATION FILM
K870147 · FRG
Cost Rite Health Products, Inc.
General Hospital · 100d
Cleared Apr 23, 1987
MODEL MICRO ST AMBULATORY ECG MONITOR
K870537 · DSH
Advanced Medical Products, Inc.
Cardiovascular · 73d
Cleared Apr 23, 1987
MODEL 192 PRINTER
K870538 · DSF
Advanced Medical Products, Inc.
Cardiovascular · 73d
Cleared Apr 23, 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET
K870581 · FPA
Strato Medical Corp.
General Hospital · 71d
Cleared Apr 23, 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE
K870582 · FPA
Strato Medical Corp.
General Hospital · 71d
Cleared Apr 23, 1987
TIMLEINE(TM) VENIPUNCTURE SYSTEM
K870770 · KMK
Ipax, Inc.
General Hospital · 56d
Cleared Apr 23, 1987
PT HEPARIN ADSORBENT
K870771 · JPA
Probe-Tek, Inc.
Hematology · 56d
Cleared Apr 23, 1987
PROTEIN S CONTROL PLASMA
K870917 · GGP
American Bioproducts Co.
Hematology · 48d
Cleared Apr 23, 1987
(I) LV AND (II) HV SERIES CANNULA
K871043 · GEA
Celebration Medical Products, Inc.
General & Plastic Surgery · 37d
Cleared Apr 23, 1987
FOUNDATIONS PLUS ABDOMINAL BAND 1100
K871138
Foundations Plus, Inc.
General & Plastic Surgery · 31d
Cleared Apr 23, 1987
PACE 10 NON-INVASIVE EXTERNAL PACEMAKER
K871176 · DRO
Medac, Inc.
Cardiovascular · 30d
Cleared Apr 23, 1987
SUN CAPSULE I & II SUNTANNING BOOTH
K871237 · FTC
Sun Capsule, Inc.
General & Plastic Surgery · 27d
Cleared Apr 23, 1987
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
K871414 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Apr 22, 1987
MATRIX LD & LD/LASER DIGITIZER
K860777 · LMA
Matrix Instruments
Radiology · 415d
Cleared Apr 22, 1987
THE FM-212A BIOFEEDBACK UNIT
K861950 · HCC
Hosa Technology, Inc.
Neurology · 337d
Cleared Apr 22, 1987
ENZYGNOST ANTI-VZV IGG TEST
K863317 · GQX
Behring Diagnostics, Inc.
Microbiology · 239d
Cleared Apr 22, 1987
EMT-102 CARDIAC MONITOR
K870049 · DXN
Evergreen Medical Technologies, Inc.
Cardiovascular · 106d
Cleared Apr 22, 1987
PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR
K870142 · DXY
Cardio-Pace Medical, Inc.
Cardiovascular · 99d
Cleared Apr 22, 1987
SPECTACLE FRAMES VARIOUS COLORS AND DESIGNS
K870179 · HQZ
Polinelli
Ophthalmic · 97d
Cleared Apr 22, 1987
BIOMEK 1000 AUTOMATED LABORATORY WORK STATION
K870544 · JQW
Beckman Instruments, Inc.
Chemistry · 72d