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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
104305–104328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 1995
NAIS WRIST BLOOD PRESSURE METER
K942423 · DXN
King & Spalding
Cardiovascular · 271d
Cleared Feb 15, 1995
BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND
K942490 · HEM
Medical Soft, Inc.
Obstetrics & Gynecology · 266d
Cleared Feb 15, 1995
ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG
K944378 · FGM
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 161d
Cleared Feb 15, 1995
ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG
K944379 · FGM
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 161d
Cleared Feb 15, 1995
ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG
K944384 · FGM
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 161d
Cleared Feb 15, 1995
HIGH DOSE RATE AFTERLOADER
K945383 · JAQ
Varian Assoc., Inc.
Radiology · 113d
Cleared Feb 15, 1995
HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS
K945731 · IZO
Bennett X-Ray Corp.
Radiology · 85d
Cleared Feb 15, 1995
BENNETT X-RAY TOMOGRAPHY SYSTEM
K945749 · IZF
Bennett X-Ray Corp.
Radiology · 84d
Cleared Feb 15, 1995
MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
K946261 · IYB
Scott Imaging Intl., Inc.
Radiology · 64d
Cleared Feb 15, 1995
EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES
K946262 · IXQ
Scott Imaging Intl., Inc.
Radiology · 64d
Cleared Feb 15, 1995
N 800 HF
K950037 · IZO
Oldelft Corp. of America
Radiology · 42d
Cleared Feb 14, 1995
CCG CERCLAGE SYSTEM
K932024 · JDQ
Encore Orthopedics, Inc.
Orthopedic · 659d
Cleared Feb 14, 1995
MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
K934065 · GZB
Medtronic Vascular
Neurology · 543d
Cleared Feb 14, 1995
THROMBOSCREEN THROMBOPLASTIN-DS
K940082 · GJS
Pacific Hemostasis
Hematology · 403d
Cleared Feb 14, 1995
TRACHEOSTOMY CARE KIT
K941470 · BTO
Clinical Resources, Inc.
Anesthesiology · 323d
Cleared Feb 14, 1995
MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT
K941717 · HPZ
Miguel Martinez M.D.
Ophthalmic · 313d
Cleared Feb 14, 1995
SELBY INSTRUMENTATION
K942387 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 271d
Cleared Feb 14, 1995
KIT PAK WET SALINE DRESSING
K942959 · FRO
Kit Pak, Inc.
General & Plastic Surgery · 236d
Cleared Feb 14, 1995
AS/3 AIRWAY MODULE
K943458 · CBS
Datex Division Instrumentarium Corp.
Anesthesiology · 211d
Cleared Feb 14, 1995
VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE
K943521 · FRA
Schiff & Co.
General Hospital · 209d
Cleared Feb 14, 1995
ARTHROSCOPE ACCESSORIES
K944210 · HRX
Stryker Endoscopy
Orthopedic · 169d
Cleared Feb 14, 1995
VENTED/NON-VENTED GEMINI ADMINISTRATION SET
K944320 · FPA
Imed Corp.
General Hospital · 169d
Cleared Feb 14, 1995
DIB INFUSORS
K944665 · MEB
Novacon Corp.
General Hospital · 155d
Cleared Feb 14, 1995
MASSAGER
K944730 · ISA
North American Technical Services Corp.
Physical Medicine · 141d