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
72337–72360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2003
WAKO L-TYPE GLUCOSE 2
K024281 · CFR
Wako Chemicals USA, Inc.
Chemistry · 63d
Cleared Feb 24, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K030042 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared Feb 24, 2003
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
K030182 · GGN
Bio-Rad
Hematology · 38d
Cleared Feb 24, 2003
BIORAPID MONONUCLEOSIS
K030215 · KTN
Instrumentation Laboratory CO
Immunology · 34d
Cleared Feb 21, 2003
PMH 1000 HEATED HUMIDIFIER
K013856 · BTT
Pegasus Research Corp.
Anesthesiology · 472d
Cleared Feb 21, 2003
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K021945 · IZH
Planmed OY
Radiology · 253d
Cleared Feb 21, 2003
MACROPORE SURGICAL BARRIER FILM
K023643 · MTZ
Macropore Biosurgery, Inc.
Ophthalmic · 114d
Cleared Feb 21, 2003
SYNTRA + DIALYZER, MODEL 200
K023664 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 113d
Cleared Feb 21, 2003
COAXIA FLOCONTROL CATHETER
K023914 · MJN
Coaxia, Inc.
Cardiovascular · 88d
Cleared Feb 21, 2003
AUTOCON II 200 ELECTROSURGICAL GENERATOR
K023924 · GEI
Karl Storz Endoscopy
General & Plastic Surgery · 88d
Cleared Feb 21, 2003
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K023929 · MOS
Advanced Imaging Research, Inc.
Radiology · 88d
Cleared Feb 21, 2003
JEROME GLASS RING
K023959 · HAX
The Jerome Group, Inc.
Neurology · 86d
Cleared Feb 21, 2003
LEO III TX/RX QUADRATURE KNEE COIL
K023982 · MOS
Usa Instruments, Inc.
Radiology · 81d
Cleared Feb 21, 2003
SABER TECH IMPLANTS SYSTEM
K024044 · DZE
Imtec Corp.
Dental · 77d
Cleared Feb 21, 2003
MERIT MEDICAL 1-ML SYRINGE
K024052 · FMF
Merit Medical Systems, Inc.
General Hospital · 77d
Cleared Feb 21, 2003
PRIMELUNG
K024149 · JAK
Accuimage Diagnostics Corp.
Radiology · 67d
Cleared Feb 21, 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT...
K024193 · MMI
Ortho-Clinical Diagnostics
Chemistry · 63d
Cleared Feb 21, 2003
TERUMO SURGUARD SAFETY SYRINGE
K024249 · MEG
Terumo Medical Corp.
General Hospital · 60d
Cleared Feb 21, 2003
THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
K024309 · BYI
Advanced Respiratory
Anesthesiology · 59d
Cleared Feb 21, 2003
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045 · DIH
Olympus America, Inc.
Chemistry · 46d
Cleared Feb 21, 2003
CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES
K030190 · MQX
Suzhou Sen Sen Medical Supplies , Ltd.
General Hospital · 31d
Cleared Feb 21, 2003
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K030240 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 29d
Cleared Feb 21, 2003
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K030241 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
K030252 · KWP
Ortho Tec, LLC
Orthopedic · 28d