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
95689–95712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1996
MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
K964267 · KPS
Trionix Research Laboratory, Inc.
Radiology · 19d
Cleared Nov 12, 1996
TRIAD 88 NUCLEAR IMAGING SYSTEM
K964268 · KPS
Trionix Research Laboratory, Inc.
Radiology · 19d
Cleared Nov 08, 1996
THERAPLAN PLUS
K954679 · IYE
Theratronics, Inc.
Radiology · 395d
Cleared Nov 08, 1996
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
K961582 · DTC
North American Technical Services Corp.
Cardiovascular · 198d
Cleared Nov 08, 1996
PHILIPS EASYGUIDE NEURO
K961834 · HAW
Philips Medical Systems, Inc.
Neurology · 179d
Cleared Nov 08, 1996
LIGHTSTIC MODEL 180
K962068 · GEX
Rare Earth Medical, Inc.
General & Plastic Surgery · 164d
Cleared Nov 08, 1996
CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)
K962364 · LMC
Codonics, Inc.
Radiology · 142d
Cleared Nov 08, 1996
PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION...
K963098 · CAC
Deknatel, Inc.
Anesthesiology · 91d
Cleared Nov 08, 1996
MMG MULTI LUMON EXTENSION SET
K963112 · FPA
Mmg Healthcare, Inc.
General Hospital · 88d
Cleared Nov 08, 1996
PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)
K963124 · GEX
Fisma, Inc.
General & Plastic Surgery · 88d
Cleared Nov 08, 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
K963172 · HWC
Synthes (Usa)
Orthopedic · 86d
Cleared Nov 08, 1996
SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS
K963192 · HWC
Synthes (Usa)
Orthopedic · 85d
Cleared Nov 08, 1996
CINCH STRAP WITH BUCKLE
K963370 · FMQ
Morrison Medical Products
General Hospital · 73d
Cleared Nov 08, 1996
TORSO/WAIST RESTRAINT
K963374 · FMQ
Morrison Medical Products
General Hospital · 73d
Cleared Nov 08, 1996
DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH...
K963387 · FMQ
Morrison Medical Products
General Hospital · 72d
Cleared Nov 08, 1996
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
K963497 · MOT
Nordion International, Inc.
Radiology · 66d
Cleared Nov 08, 1996
PACE-1A CARDIAC STIMULATOR
K963579 · JOQ
Radionics, Inc.
Cardiovascular · 63d
Cleared Nov 08, 1996
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120
K963617 · JAA
Shimadzu Medical Systems
Radiology · 59d
Cleared Nov 08, 1996
AIA-PACK FT3 ASSAY
K963687 · CDP
Tosoh Medics, Inc.
Chemistry · 53d
Cleared Nov 08, 1996
HEMOCUE GLUCOLIN
K963909 · JJX
Direct Solutions
Chemistry · 39d
Cleared Nov 08, 1996
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
K963915 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 08, 1996
STP SYSTEM PVA WITH ZINC
K963986 · LIO
Sage Products, Inc.
Microbiology · 35d
Cleared Nov 07, 1996
NAVARRE PERCUTANEOUS BILIARY DRAINAGE
K955110 · FGE
Navarre Biomedical , Ltd.
Gastroenterology & Urology · 365d
Cleared Nov 07, 1996
PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH...
K960855 · CGA
Home Diagnostics, Inc.
Chemistry · 251d