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
123865–123888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1990
SHEPPERD CANNULA STILLETTE & OBDURATOR SET
K900610 · HRX
Downs Surgical , Ltd.
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD DILATATION TUBE SET (GS-501-20-H)
K900611 · HRX
Downs Surgical , Ltd.
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD TREPHINE SET (GS-501-30-V)
K900612 · HRX
Downs Surgical , Ltd.
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD SHELTER TUBE COMPLETE & DRILL
K900613 · HRX
Downs Surgical , Ltd.
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V)
K900614 · HRX
Downs Surgical , Ltd.
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE
K900615 · HRX
Downs Surgical , Ltd.
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD CUTTING FORCEPS
K900616 · HRX
Downs Surgical , Ltd.
Orthopedic · 256d
Cleared Oct 22, 1990
SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC
K900647 · IPF
Nor-Am Patient Care Products, Inc.
Physical Medicine · 255d
Cleared Oct 22, 1990
CORADENT
K901260 · EBF
Ivoclar North America, Inc.
Dental · 221d
Cleared Oct 22, 1990
GSB ELBOW
K901581 · JDC
Allo Pro Corp.
Orthopedic · 201d
Cleared Oct 22, 1990
MODEL MD-5 DOPPLER
K901592 · DXK
D. E. Hokanson, Inc.
Cardiovascular · 200d
Cleared Oct 22, 1990
FETAL PULSE DETECTOR MODEL DOP-1
K902190 · HEK
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 159d
Cleared Oct 22, 1990
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599 · IPF
Chattanooga Group, Inc.
Physical Medicine · 132d
Cleared Oct 22, 1990
SPO2 OPTION
K902730 · DQA
Protocol Systems, Inc.
Anesthesiology · 123d
Cleared Oct 22, 1990
TROPI-COOL
K902756 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 122d
Cleared Oct 22, 1990
ROZINN 151
K903331 · DSH
Rozinn Electronics, Inc.
Cardiovascular · 89d
Cleared Oct 22, 1990
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K903348 · HGL
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 22, 1990
OSTEOLOCK(TM) ACETABULAR CUP
K903362 · JDI
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 22, 1990
SOEHENDRA STENT RETRIEVER
K903420 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Oct 22, 1990
LIFECOIL CATHETER
K903502 · FJS
Lifemed of California
Gastroenterology & Urology · 80d
Cleared Oct 22, 1990
PERCUTANEOUS INTRODUCERS
K903530 · DYB
Davol, Inc.
Cardiovascular · 77d
Cleared Oct 22, 1990
KEJUMP DIGITAL CLINICAL THERMOMETER
K903590 · FLL
K-Jump Health Co., Ltd.
General Hospital · 75d
Cleared Oct 22, 1990
SEROTONIN ENZYME IMMUNOASSAY
K903609 · CDA
Immunotech Corp.
Chemistry · 74d
Cleared Oct 22, 1990
PATIENT EXAMINATION GLOVES
K903703 · LYY
P.T. Tulip Indah Agung
General Hospital · 68d