Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
169969–169992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1979
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO
K790938 · DWP
Shiley, Inc.
Cardiovascular · 26d
Cleared Jun 13, 1979
VOLUREX TM
K791015 · BWF
Dhd Medical Products Div. Diemolding...
Anesthesiology · 12d
Cleared Jun 13, 1979
I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL
K791042 · CAF
Airlife, Inc.
Anesthesiology · 8d
Cleared Jun 13, 1979
LINDE OXYGEN CONCENTRATOR MODEL LOC-HC
K791043 · CAW
Union Carbide Corp.
Anesthesiology · 8d
Cleared Jun 13, 1979
TRACHEOSTOMY TUBES, SHORT AND LONG TERM
K791044 · BTO
Extracorporeal Medical Specialities,...
Anesthesiology · 8d
Cleared Jun 13, 1979
MODEL GV-10 LANZ PRESSURE-VALVE
K791045 · BTR
Extracorporeal Medical Specialities,...
Anesthesiology · 8d
Cleared Jun 13, 1979
ENDOTRACHEAL TUBES, LONG & SHORT TERM
K791046 · BTR
Extracorporeal Medical Specialities,...
Anesthesiology · 8d
Cleared Jun 13, 1979
NERVE STIMULATOR, DIGITAL PERIPHERAL
K791047 · BXN
C.R. Bard, Inc.
Anesthesiology · 7d
Cleared Jun 12, 1979
ESTERASE-CHLOROESTERASE, STAINING KIT
K791092
Eureka Laboratories, Inc.
Hematology
Cleared Jun 11, 1979
ELECATH MULTI-PURPOSE ARTERIAL SURGER
K790444 · GBA
Electro-Catheter Corp.
General & Plastic Surgery · 97d
Cleared Jun 11, 1979
SANDEE SANDING BLOCK
K790504 · LDQ
Dr. Bertram L. Steel
General & Plastic Surgery · 90d
Cleared Jun 11, 1979
AORTIC ROOT CANNULA
K790565 · DWF
Dlp, Inc.
Cardiovascular · 84d
Cleared Jun 11, 1979
HEAT EXCHANGER COIL
K790756 · DTR
Delta Medical Industries
Cardiovascular · 55d
Cleared Jun 11, 1979
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
K790838 · DXE
Shiley, Inc.
Cardiovascular · 41d
Cleared Jun 11, 1979
LEAD INTRODUCER SET
K790882 · DQX
Introstat
Cardiovascular · 34d
Cleared Jun 11, 1979
MODEL 78501A PATIENT MONITORING SYSTEM
K790939 · DPS
Hewlett-Packard Co.
Cardiovascular · 24d
Cleared Jun 11, 1979
ULTRASONIC HUMIDIFIER
K790966 · KFZ
Hankscraft Div. of Gerber Products Co.
Anesthesiology · 20d
Cleared Jun 11, 1979
CATHETER METAL HUB/NONRADIOPAQUE
K790968 · FOZ
Jelco Laboratories
General Hospital · 20d
Cleared Jun 11, 1979
MODEL 6971 W/ DBS WIRE
K790988 · DTB
Medtronic Vascular
Cardiovascular · 17d
Cleared Jun 11, 1979
CONTEX
K790995 · FMP
Foam Tek, Inc.
General Hospital · 13d
Cleared Jun 11, 1979
SMART BILECTRODES
K791006 · DRX
Electronics For Medicine, Inc.
Cardiovascular · 11d
Cleared Jun 11, 1979
SANTA CASA DISTRACTOR
K791009 · KWP
Depuy, Inc.
Orthopedic · 11d
Cleared Jun 07, 1979
CLAYTON COLON CLEANSING KIT
K790535 · FCE
Clayton Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 06, 1979
STRESS TESTING SYSTEM, LATERAL TILTING
K790545 · DRT
Engineering Dynamics Corp.
Cardiovascular · 78d