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
119257–119280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1991
AESCULAP TITANIUM BONE SCREWS
K913415 · HWC
Aesculap, Inc.
Orthopedic · 90d
Cleared Oct 28, 1991
STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)
K910778 · FLE
Mdt Biologic Co.
General Hospital · 248d
Cleared Oct 28, 1991
FLEX-IV
K911251 · FOZ
Medway
General Hospital · 221d
Cleared Oct 28, 1991
ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR
K911965 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 179d
Cleared Oct 28, 1991
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
K912014 · EGJ
Empi
Physical Medicine · 175d
Cleared Oct 28, 1991
VISION (NUCLEAR MEDICINE COMPUTER)
K912573 · KPS
Summit Nuclear
Radiology · 139d
Cleared Oct 28, 1991
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
K912604 · KFM
Aries Medical, Inc.
Cardiovascular · 150d
Cleared Oct 28, 1991
SCEPTOR IDENTIFICATION SYSTEM
K912897 · LQM
Bd Becton Dickinson Vacutainer...
Microbiology · 119d
Cleared Oct 28, 1991
CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE
K912987 · GEX
Douglas James Donaldson Compliance...
General & Plastic Surgery · 112d
Cleared Oct 28, 1991
OPUS(R) ANTI CMV-M
K913080 · LKQ
Pb Diagnostics, Inc.
Microbiology · 109d
Cleared Oct 28, 1991
KAR-D-TEK
K913405 · LFC
Gresco Products, Inc.
Dental · 90d
Cleared Oct 28, 1991
TETLEY PATIENT ADMINISTRATION SET
K913416 · IYT
Tetley Medical , Ltd.
Radiology · 89d
Cleared Oct 28, 1991
.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE
K913631 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 74d
Cleared Oct 28, 1991
PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT
K913760 · FTC
Psoralite Corp.
General & Plastic Surgery · 67d
Cleared Oct 28, 1991
MONOSCOPY(TM) BRAND, ENDOBAG
K913762 · GCJ
Dexide, Inc.
General & Plastic Surgery · 67d
Cleared Oct 28, 1991
DAIG FAST CATH(TM) INTRODUCER, MODIFICATION
K914090 · DYB
Daig Corp.
Cardiovascular · 47d
Cleared Oct 28, 1991
DERMASAFE(TH) HYPOALLERGENIC
K914094 · LYY
Multi-Com Sdn Bhd
General Hospital · 46d
Cleared Oct 28, 1991
LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR
K914098 · GCJ
Surgical Innovations Corp.
General & Plastic Surgery · 46d
Cleared Oct 28, 1991
C1 RID KIT
K914388 · DAK
The Binding Site, Ltd.
Immunology · 27d
Cleared Oct 28, 1991
ACTION SERIES MANUAL WHEELCHAIRS, VARIOUS MODELS
K914553 · IOR
Invacare Corp.
Physical Medicine · 17d
Cleared Oct 25, 1991
RAY SACRAL FIXATION SYSTEM
K904520 · KWP
Danek Medical, Inc.
Orthopedic · 387d
Cleared Oct 25, 1991
STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
K911354 · GAL
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 213d
Cleared Oct 25, 1991
FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT
K911972 · JWH
Intermedics Orthopedics
Orthopedic · 175d
Cleared Oct 25, 1991
BIO TENS 601, 606 AND 608 (3000)
K912178 · GZJ
Skylark Device Co., Ltd.
Neurology · 162d