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
78625–78648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2001
SIMPLICITY SOFT QD SILVER INFUSION SET
K011580 · FPA
Sterling Medivations, Inc.
General Hospital · 14d
Cleared Jun 04, 2001
INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
K003472 · CAW
Sequal Technologies, Inc.
Anesthesiology · 208d
Cleared Jun 04, 2001
TDP CQ-27 HEAT LAMP
K003538 · ILY
Lhasa Medical, Inc.
Physical Medicine · 200d
Cleared Jun 04, 2001
CONTINUOUS FLOW Y-TUBING
K010122 · LJH
G.U.-Tek
Gastroenterology & Urology · 139d
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658 · MNI
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 04, 2001
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
K010667 · KDI
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Jun 04, 2001
NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1
K010669 · GWQ
Thuris Corp.
Neurology · 90d
Cleared Jun 01, 2001
SPINAL EPIDURAL NEEDLES
K002405 · BSP
Te ME NA S.A.R.L.
Anesthesiology · 298d
Cleared Jun 01, 2001
JET SYRINGE MODEL-100500
K003741 · KZE
Equidyne Systems, Inc.
General Hospital · 179d
Cleared Jun 01, 2001
RESPIRATORY HUMIDIFIER, MODEL HC150
K003973 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 161d
Cleared Jun 01, 2001
PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K003992 · NFA
Percu Surge, Inc.
Cardiovascular · 157d
Cleared Jun 01, 2001
KOKO PEAK KP
K010009 · BZH
Pds Healthcare Products, Inc.
Anesthesiology · 150d
Cleared Jun 01, 2001
VERDICT -II METHAMPHETAMINE
K010226 · DJC
Medtox Diagnostics, Inc.
Toxicology · 128d
Cleared Jun 01, 2001
ISCREEN VISION SCREENER
K010315 · HKI
Iscreen, LLC
Ophthalmic · 119d
Cleared Jun 01, 2001
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K011020 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 58d
Cleared Jun 01, 2001
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared Jun 01, 2001
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
K011587 · LZH
Entracon Corp.
General Hospital · 9d
Cleared May 31, 2001
ESU HANDSWITCHING PENCIL
K001442 · GEI
Surgex, Inc.
General & Plastic Surgery · 388d
Cleared May 31, 2001
CADHEALTH SYSTEM, MODEL CHP-001
K002514 · DRG
Caduceus Health Care , Ltd.
Cardiovascular · 289d
Cleared May 31, 2001
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
K002847 · DYB
Maxxim Medical
Cardiovascular · 260d
Cleared May 31, 2001
NAT - NUCLEIC ACID TRANSPORT
K003761 · LIO
Medical Packaging Corp.
Microbiology · 176d
Cleared May 31, 2001
LAPAROSCOPIC HAND PORT
K003871 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 167d
Cleared May 31, 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 90d
Cleared May 31, 2001
VERSYO.COM
K010800 · EBI
Heraeus Kulzer, Inc.
Dental · 76d