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
169129–169152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 06, 1979
DRUG ABUSE DIPSTICKS
K790805 · DIT
Technical Resources, Inc.
Toxicology · 42d
Cleared Jun 05, 1979
STRESS TESTING SYSTEM, MULTI-POSITION
K790544 · DRT
Engineering Dynamics Corp.
Cardiovascular · 75d
Cleared Jun 05, 1979
FETAL MATURITY TEST PROCEDURE
K790798 · JHG
Helena Laboratories
Chemistry · 49d
Cleared Jun 05, 1979
MEDI-TRACE EEG CREME
K790818 · GYB
Graphic Controls Corp.
Neurology · 39d
Cleared Jun 05, 1979
FORCEPS #101 AND #102
K790854 · GEN
C. Intl.
General & Plastic Surgery · 32d
Cleared Jun 05, 1979
AMALCAP-NON-GAMMA-2
K790874 · EJJ
Vivadent (Usa), Inc.
Dental · 29d