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
130873–130896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 1989
AMRESCO URIC ACID REAGENTS #7628
K892395 · KNK
American Research Products Co.
Chemistry · 47d
Cleared May 24, 1989
SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED
K892522 · GKB
Gespac, Inc.
Hematology · 43d
Cleared May 24, 1989
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
K892648 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 42d
Cleared May 24, 1989
SDI PREPAX COUNTAPETTE KIT
K892658 · JCG
Scientific Distributors, Inc.
Hematology · 41d
Cleared May 24, 1989
ARGEDENT 87
K892662 · EJT
Argen Precious Metals, Inc.
Dental · 41d
Cleared May 24, 1989
S-FILE, S-FINDER, S-ENGINE FILE
K892894 · EKS
Svenska Dental Instruments AB
Dental · 34d
Cleared May 24, 1989
ARGELITE 60+
K893012 · EJT
Argen Precious Metals, Inc.
Dental · 30d
Cleared May 23, 1989
MRL BLOOD PRESSURE MONITOR
K885191 · DXN
Medical Research Laboratories, Inc.
Cardiovascular · 158d
Cleared May 23, 1989
THE CDI(R) SYSTEM 400
K890113 · DJY
Cardiovascular Devices, Inc.
Toxicology · 132d
Cleared May 23, 1989
ENTERAL BAG/SET
K890151 · KNT
Ashley Health Care, Inc.
Gastroenterology & Urology · 130d
Cleared May 23, 1989
EXTERNAL FEEDING SET FOR PUMP USE
K890396 · FPD
Multi-Med, Inc.
Gastroenterology & Urology · 119d
Cleared May 23, 1989
CLOSED SYSTEM URINARY DRAINAGE BAG
K890465 · EYZ
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 112d
Cleared May 23, 1989
PERIPHERAL ATHERECTOMY SYSTEM
K890515 · DWX
Intensive Technology, Inc.
Cardiovascular · 111d
Cleared May 23, 1989
BEAM TECH WOUND DRESSING*
K890603 · NAD
Beam Tech , Ltd.
General & Plastic Surgery · 106d
Cleared May 23, 1989
MCINTYRE SURGICAL GONIOLENS
K890977 · HKS
Ocular Instruments, Inc.
Ophthalmic · 85d
Cleared May 23, 1989
LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC
K891130 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 81d
Cleared May 23, 1989
TECNOL SECURE-ALL TUBE HOLDER
K891178 · EYZ
Tecnol New Jersey Wound Care, Inc.
Gastroenterology & Urology · 78d
Cleared May 23, 1989
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
K891290 · HES
Cook Ob/Gyn
Obstetrics & Gynecology · 74d
Cleared May 23, 1989
WILLIAMS BELT & BOOT
K891387 · JEB
Arthro-Medic, Inc.
General & Plastic Surgery · 70d
Cleared May 23, 1989
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
K891601 · HQE
Mira, Inc.
Ophthalmic · 64d
Cleared May 23, 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006 · DRT
Healthdyne, Inc.
Cardiovascular · 56d
Cleared May 23, 1989
GRAND GUARD SURGICAL GLOVES
K892061 · KGO
Galaxy Intl., Inc.
General Hospital · 54d
Cleared May 23, 1989
BIPOLAR HIP SYSTEM
K892398 · KXA
Orthomet, Inc.
Orthopedic · 46d
Cleared May 23, 1989
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE
K893013 · GEX
Luxar Medical Laser Instruments
General & Plastic Surgery · 29d