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
96793–96816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1996
HP SONOS ULTRASOUND IMAGING SYSTEM
K954028 · IYN
Hewlett-Packard Co.
Radiology · 346d
Cleared Aug 08, 1996
BIEGLER BW385L BLOOD & INFUSION WARMER
K954769 · LGZ
Biegler Medical Products, Inc.
General Hospital · 297d
Cleared Aug 08, 1996
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
K954987 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 282d
Cleared Aug 08, 1996
TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
K954996 · KHW
Trend Scientific, Inc.
Microbiology · 281d
Cleared Aug 08, 1996
TAPE & BANDAGE, ADHESIVE
K955270 · DXC
Robert R. Stevens
Cardiovascular · 267d
Cleared Aug 08, 1996
FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70
K955525 · KRA
Interventional Innovations Corp.
Cardiovascular · 248d
Cleared Aug 08, 1996
TOWNLEY TOTAL ELBOW SYSTEM
K955916 · JDC
Biologically Oriented Prostheses
Orthopedic · 223d
Cleared Aug 08, 1996
SPREADABLE SHEATH INTRODUCER SET
K960625 · DYB
Neostar Medical Technologies, Inc.
Cardiovascular · 177d
Cleared Aug 08, 1996
MENTOR ADVENT A/B SYSTEM
K960765 · IYO
Mentor Ophthalmics, Inc.
Radiology · 164d
Cleared Aug 08, 1996
SRRS PRESSED FIT FEMORAL REVISION COMPONENT
K960908 · LWJ
Stelkast Company
Orthopedic · 156d
Cleared Aug 08, 1996
FIRST BEAT/CARDIO BEAT/CALC
K961116 · IYO
Medasonics, Inc.
Radiology · 141d
Cleared Aug 08, 1996
ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
K961194 · GBW
Sil-Med Corp.
General & Plastic Surgery · 134d
Cleared Aug 08, 1996
BODYTRODE
K961288 · DRX
Marquette Electronics, Inc.
Cardiovascular · 126d
Cleared Aug 08, 1996
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
K961752 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 94d
Cleared Aug 08, 1996
SIEMENS BEAM SHAPER
K961902 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Aug 08, 1996
QUALITROL SYPHSERO CONTROL SET
K961998 · GMP
Consolidated Technologies, Inc.
Microbiology · 78d
Cleared Aug 08, 1996
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
K962002 · JDG
Exactech, Inc.
Orthopedic · 78d
Cleared Aug 08, 1996
SILKON STAINLESS STEEL CABLE SYSTEM
K962132 · JDQ
Osteonics Corp.
Orthopedic · 66d
Cleared Aug 08, 1996
BACTEC 9050 SYSTEM
K962210 · MDB
Becton Dickinson Diagnostic...
Microbiology · 59d
Cleared Aug 08, 1996
PAPILLOTOME
K962346 · KNS
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 51d
Cleared Aug 08, 1996
CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS
K962362 · DQY
Cordis Corp.
Cardiovascular · 50d
Cleared Aug 07, 1996
ADULT-PEDIATRIC TRANSPORT SYSTEM
K955766 · FPO
International Biomedical, Inc.
General Hospital · 231d
Cleared Aug 07, 1996
PRUITT SAFETY OCCLUSION CATHETER
K960422 · MJN
Ideas For Medicine, Inc.
Cardiovascular · 191d
Cleared Aug 07, 1996
CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
K960544 · DRT
Nasiff Assoc., Inc.
Cardiovascular · 182d