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
84889–84912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1999
INTERMITTENT COMPRESSION BOOT FOR OTC
K991921 · IRP
Eischoco, Inc.
Physical Medicine · 67d
Cleared Aug 13, 1999
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
K991958 · LJL
Kiel Laboratories, Inc.
General Hospital · 64d
Cleared Aug 13, 1999
SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE...
K991960 · GEI
Stryker Endoscopy
General & Plastic Surgery · 64d
Cleared Aug 13, 1999
INFANT FLOW SYSTEM
K991972 · BZD
Sensor Medics Corp.
Anesthesiology · 63d
Cleared Aug 13, 1999
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
K992025 · MEH
Howmedica Osteonics Corp.
Orthopedic · 58d
Cleared Aug 13, 1999
SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM
K992046 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Aug 13, 1999
DYNAWELL OR DYNAWELL
K992120 · LNH
Ekeroth Quality AB
Radiology · 51d
Cleared Aug 13, 1999
MONARCH II MINI MASK
K992336 · BZD
Respironics, Inc.
Anesthesiology · 31d
Cleared Aug 13, 1999
NORODYN 8000 SEMG SYSTEM, ND-8000
K992439 · HCC
Myotronics-Noromed, Inc.
Neurology · 22d
Cleared Aug 13, 1999
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462 · LZN
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Aug 12, 1999
THERADYNE ROVER POWERED WHEELCHAIR
K982724 · ITI
Kurt Mfg. Co.
Physical Medicine · 372d
Cleared Aug 12, 1999
NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847
K982969 · CCK
Nonin Medical, Inc.
Anesthesiology · 352d
Cleared Aug 12, 1999
FETALGARD 3000 FETAL MONITOR
K983395 · HGM
Analogic Corp.
Obstetrics & Gynecology · 321d
Cleared Aug 12, 1999
RIWO DRIVE GENERATOR
K984304 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 253d
Cleared Aug 12, 1999
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
K984567 · MYA
Ventana, Inc.
Pathology · 232d
Cleared Aug 12, 1999
AB2 MED-FLO SOLUTION SET
K984569 · FPA
Ab2 Medical Products, Llp
General Hospital · 232d
Cleared Aug 12, 1999
DRAINAGE BAG
K990428 · EXF
Remington Medical, Inc.
Gastroenterology & Urology · 182d
Cleared Aug 12, 1999
GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
K990440 · MGQ
Gentell
General & Plastic Surgery · 182d
Cleared Aug 12, 1999
REMOTE INTRODUCER, MODEL PI-1000
K990907 · HAW
Image-Guided Neurologics, Inc.
Neurology · 147d
Cleared Aug 12, 1999
PMS 750 FINGERSWITCH
K991669 · GEI
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 90d
Cleared Aug 12, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM,...
K991674 · FGE
Cordis Corp.
Gastroenterology & Urology · 87d
Cleared Aug 12, 1999
WHITESIDE BIOMECHANICS SPINAL SYSTEM
K991678 · KWQ
Whiteside Biomechanics, Inc.
Orthopedic · 87d
Cleared Aug 12, 1999
OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM,...
K991718 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 84d
Cleared Aug 12, 1999
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
K991757 · EFQ
Furlong Industries
General & Plastic Surgery · 80d