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
71473–71496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2003
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC
K030699 · EAG
J. Morita Mfg. Corp.
Radiology · 84d
Cleared May 29, 2003
IPACS PRISM
K030751 · LLZ
Realtimeimage, Inc.
Radiology · 80d
Cleared May 29, 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW...
K030781 · LLZ
Eastman Kodak Company
Radiology · 79d
Cleared May 29, 2003
LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
K031011 · GEI
Valleylab, Inc.
General & Plastic Surgery · 59d
Cleared May 29, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K031139 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
ALPHA 5000 WRIST COIL
K031143 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K031172 · MOS
Usa Instruments, Inc.
Radiology · 45d
Cleared May 29, 2003
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K031286 · GAM
Aesculap, Inc.
General & Plastic Surgery · 36d
Cleared May 29, 2003
THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
K031481 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 17d
Cleared May 28, 2003
WATER PURIFICATION SYSTEM
K022448 · FIP
Purity Water Company of San Antonio,...
Gastroenterology & Urology · 306d
Cleared May 28, 2003
PAPILLON MASK SET
K023068 · BZD
Map Medizintechnik Fur Arzt Und...
Anesthesiology · 254d
Cleared May 28, 2003
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
K023662 · MCF
Hwadong International Company , Ltd.
Dental · 209d
Cleared May 28, 2003
ENCORE ANTERIOR SPINAL STAPLE SYSTEM
K030667 · KWQ
Encore Medical, L.P.
Orthopedic · 86d
Cleared May 28, 2003
IN-VISION IMAGING SYSTEM
K031148 · DXK
Jomed, Inc.
Cardiovascular · 48d
Cleared May 28, 2003
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K031219 · HSB
Orthofix, Inc.
Orthopedic · 41d
Cleared May 27, 2003
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
K012889 · MED
Pascal Co., Inc.
General Hospital · 637d
Cleared May 27, 2003
COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM
K023937 · DYB
Cook Vascular, Inc.
Cardiovascular · 182d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared May 27, 2003
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618 · BSP
Wilson-Cook Medical, Inc.
Anesthesiology · 90d
Cleared May 27, 2003
APTUS BLUE
K030884 · KJJ
Acadental
Dental · 68d
Cleared May 27, 2003
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K031610 · MCW
Rex Medical
Cardiovascular · 5d
Cleared May 23, 2003
PATHWAY STM-10 PELVIC FLOOR STIMULATOR
K030039 · KPI
The Prometheus Group
Gastroenterology & Urology · 137d
Cleared May 23, 2003
AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
K030230 · DXN
Avita Corporation
Cardiovascular · 121d
Cleared May 23, 2003
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
K030398 · DQR
Cardiacassist, Inc.
Cardiovascular · 106d