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
84433–84456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1999
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
K992882 · HAW
Elekta Instrument AB
Neurology · 29d
Cleared Sep 24, 1999
RENEW RECEIVER
K992946 · GZB
Advanced Neuromodulation Systems
Neurology · 23d
Cleared Sep 24, 1999
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD,...
K992972 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Sep 24, 1999
ELECSYS ESTRADIOL CALSET II
K992981 · JIT
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Sep 24, 1999
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
K992986 · CAF
Salter Labs
Anesthesiology · 21d
Cleared Sep 24, 1999
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
K992988 · CGA
Home Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 23, 1999
E100M VENTILATOR (E100M)
K972833 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 785d
Cleared Sep 23, 1999
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE,...
K990241 · LLZ
Accuimage Diagnostics Corp.
Radiology · 241d
Cleared Sep 23, 1999
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE...
K990660 · JXG
Nmt Neurosciences Implants S.A.
Neurology · 206d
Cleared Sep 23, 1999
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
K990960 · LKD
Perimed, Inc.
Anesthesiology · 185d
Cleared Sep 23, 1999
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
K991551 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 143d
Cleared Sep 23, 1999
AGILITY STEERABLE GUIDEWIRE
K991646 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 133d
Cleared Sep 23, 1999
SORING GMBH, SONOCA 300
K992026 · BTA
Soring GmbH Medizintechnik
General & Plastic Surgery · 99d
Cleared Sep 23, 1999
PE-PLUS ACETABULAR CUP
K992153 · JDI
Plus Orthopedics
Orthopedic · 90d
Cleared Sep 23, 1999
SURGISIS SLING
K992159 · PAG
Cook Biotech, Inc.
General & Plastic Surgery · 90d
Cleared Sep 23, 1999
MOSS MIAMI 6.35MM POLYAXIAL SCREW
K992168 · KWQ
Depuyacromed
Orthopedic · 87d
Cleared Sep 23, 1999
MIRACLEBREATH TONGUE CLEANER
K992270 · LCN
Stellar Labs, Inc.
Dental · 79d
Cleared Sep 23, 1999
MICRO-FRANCE LIPOSUCTION CANNULAS
K992282 · QPB
Xomed, Inc.
General & Plastic Surgery · 78d
Cleared Sep 23, 1999
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
K992348 · JDS
Synthes (Usa)
Orthopedic · 71d
Cleared Sep 23, 1999
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
K992367 · HWC
Electro-Biology, Inc.
Orthopedic · 70d
Cleared Sep 23, 1999
ARTHROSCOPE / MEDIFIX INC.
K992474 · HRX
Medifix, Inc.
Orthopedic · 59d
Cleared Sep 23, 1999
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
K992480 · HET
Medifix, Inc.
Obstetrics & Gynecology · 59d
Cleared Sep 23, 1999
A-18 HEMODIALYZER
K992565 · FJI
Althin Medical AB
Gastroenterology & Urology · 52d
Cleared Sep 23, 1999
PHOTON RADIOSURGERY SYSTEM (PRS)
K992577 · JAD
Photoelectron Corporation
Radiology · 52d