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
91921–91944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1997
FOTONA SKINLIGHT PLUS ND: YAG SYSTEM
K972368 · GEX
Medical Laser Solutions
General & Plastic Surgery · 90d
Cleared Sep 23, 1997
EZ SPRAY
K972397 · CCQ
Intertex Research, Inc.
Anesthesiology · 89d
Cleared Sep 23, 1997
ADVANTAGE WINDOWS VOLUME RENDERING OPTION
K972399 · JAK
Ge Medical Systems, Inc.
Radiology · 89d
Cleared Sep 23, 1997
MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH
K972426 · HIH
Imagyn Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Sep 23, 1997
ANORECTAL MANOMETRY ANALYSIS MODULE
K972439 · FFX
Medtronic-Synectics
Gastroenterology & Urology · 85d
Cleared Sep 23, 1997
Z DEQ-II
K973266 · ESD
Electone, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 22, 1997
IMMULITE CEA
K970877 · DHX
Diagnostic Products Corp.
Immunology · 196d
Cleared Sep 22, 1997
ULTRASOUND SYSTEMS DRAPE
K970885 · MMP
Protek Medical Products, Inc.
General Hospital · 195d
Cleared Sep 22, 1997
T1 LINE DENTAL HANDPIECES
K972436 · EFB
Siemens AG
Dental · 84d
Cleared Sep 22, 1997
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972462 · LOJ
Bayer Corp.
Immunology · 83d
Cleared Sep 22, 1997
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972580 · JMM
Bayer Corp.
Chemistry · 74d
Cleared Sep 22, 1997
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
K972631 · GWN
Ics Medical Corp.
Neurology · 70d
Cleared Sep 22, 1997
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
K972743 · CGX
Sigma Diagnostics, Inc.
Chemistry · 61d
Cleared Sep 22, 1997
MODIFIED CEDIA DAU PCP ASSAY
K972963 · LCM
Boehringer Mannheim Corp.
Toxicology · 42d
Cleared Sep 22, 1997
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
K972969 · GIO
Innovative Medical Technologies, Inc.
Hematology · 42d
Cleared Sep 22, 1997
SYNCHRON SYSTEMS METHADONE REAGENT
K973069 · DJR
Beckman Instruments, Inc.
Toxicology · 35d
Cleared Sep 19, 1997
TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
K965154 · LRT
Albert Browne , Ltd.
General Hospital · 270d
Cleared Sep 19, 1997
DIGI-INJECTOR
K971067 · MRH
Medical Instrument Development...
Ophthalmic · 179d
Cleared Sep 19, 1997
DINAMAP MPS PORTABLE MONITOR
K971569 · MSX
Johnson & Johnson Medical, Inc.
Cardiovascular · 143d
Cleared Sep 19, 1997
DIGENE CERVICAL BRUSH
K971586 · HHT
Digene Corp.
Obstetrics & Gynecology · 141d
Cleared Sep 19, 1997
PIONEER ELEC-TROCAR DEVICE
K971728 · GEI
Pioneer Surgical Technology
General & Plastic Surgery · 133d
Cleared Sep 19, 1997
GR100F URINE FLOWMETER
K971913 · EXY
Albyn Medical , Ltd.
Gastroenterology & Urology · 120d
Cleared Sep 19, 1997
KENTRON'S ISOLATION GOWN
K971917 · FYC
Kentron Health Care, Inc.
General Hospital · 119d
Cleared Sep 19, 1997
AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
K971984 · MCW
Microvena Corp.
Cardiovascular · 113d