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
155881–155904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1983
ACUFLEX LEVY ACL DRILL GUIDE SYS
K832277 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 35d
Cleared Aug 16, 1983
MARK I TOTAL KNEE SYS. ARTHROPLASTY
K832302 · MBV
Advanced Biosearch Assn.
Orthopedic · 33d
Cleared Aug 16, 1983
US-1000 ULTRASONIC IMAGING SYSTEM
K832331 · IYO
Nidek, Inc.
Radiology · 29d
Cleared Aug 16, 1983
MEDIC LUX DIAGNOSTIC SETS
K832437 · HLJ
Keeler Instruments, Inc.
Ophthalmic · 22d
Cleared Aug 16, 1983
POLYCORE
K832461
Polycore Optical Pte , Ltd.
Ophthalmic · 21d
Cleared Aug 16, 1983
MASSAGE TABLE AAT-100
K832464 · JFB
R&D Systems, Inc.
Physical Medicine · 21d
Cleared Aug 16, 1983
GAMMA SLIDE TEST FOR PREGNANCY
K832473 · JHJ
Gamma Biologicals, Inc.
Chemistry · 21d
Cleared Aug 16, 1983
OCULOPRESSOR
K832477
Hans Gevder
Ophthalmic · 21d
Cleared Aug 16, 1983
SCOLIOMETER
K832494
Orthopedic Systems, Inc.
Physical Medicine · 20d
Cleared Aug 13, 1983
VASCULAR GRAFT/BIFURCATED/FEP-RINGED
K830806 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 152d
Cleared Aug 12, 1983
GELIPERM TRANSPARENT GEL-FILM DRESSING
K822058 · FRO
Hamel, Park, Mccabe & Saunders
General & Plastic Surgery · 395d
Cleared Aug 12, 1983
GELIPERM DRY
K822073 · FRO
Hamel, Park, Mccabe & Saunders
General & Plastic Surgery · 393d
Cleared Aug 12, 1983
GELIPERM GRANULES
K823225 · FRO
Geistlich-Pharma
General & Plastic Surgery · 287d
Cleared Aug 12, 1983
BIOELECTRICAL IMPEDANCE ANALYZER #101
K830292 · DSB
Rjl Systems, Inc.
Cardiovascular · 197d
Cleared Aug 12, 1983
CARDIO-ESOPHASCOPE
K830716 · BZT
Portex, Inc.
Anesthesiology · 157d
Cleared Aug 12, 1983
BLOOD PRESSURE MONITORING KITS,WALRUS
K830754 · DXT
Medical Parameters, Inc.
Cardiovascular · 155d
Cleared Aug 12, 1983
GONOCHEK PANEL
K830756 · JTO
E-Y Laboratories, Inc.
Microbiology · 155d
Cleared Aug 12, 1983
POLYCHACO INDIRECT HEMAGGLUTINATION
K830870 · GMM
Parasitic Disease Consultants
Microbiology · 147d
Cleared Aug 12, 1983
EXTERNAL VALVE FUNCTION BLOCK
K830914 · DRQ
Honeywell, Inc.
Cardiovascular · 141d
Cleared Aug 12, 1983
XCEL MODEL XE-1
K830992 · GZJ
Electrocaine Medical System
Neurology · 136d
Cleared Aug 12, 1983
TUFCOTE EPILATION PROBE
K831048 · KCW
Serapis Medical Electronics, Co.
General & Plastic Surgery · 134d
Cleared Aug 12, 1983
CEILING MOUNTED SUPPORT
K831086 · FQO
Amsco Co.
General & Plastic Surgery · 130d
Cleared Aug 12, 1983
EPCOM EMS-310 INTRAPARTUM MONITOR
K831113 · HGM
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 129d
Cleared Aug 12, 1983
EPCOM EMS-330 FREEDOM I TELEDOP OBSTET
K831114 · HGM
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 129d