FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95497–95520 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1997
SKYWAY
K964682 · IOR
Kid'S Wheel-Chairs
Physical Medicine · 52d
Cleared Jan 13, 1997
TAOS 28
K964940 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
EL DORADO 40
K964941 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
AURORA 52 (PM-01)
K964948 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
AURORA 53
K964949 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
LA PLATA 28 (PM-28)
K964950 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
K965171 · JJY
Bio-Rad
Chemistry · 20d
Cleared Jan 10, 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE...
K955384 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 415d
Cleared Jan 10, 1997
HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
K960966 · FRF
Sunbeam-Oster Household Products
General Hospital · 305d
Cleared Jan 10, 1997
MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
K962001 · FMI
Manan Medical Products, Inc.
General Hospital · 233d
Cleared Jan 10, 1997
VOLMETRIC COINCIDENCE DETECTION SYSTEM
K962100 · KPS
Elscint, Inc.
Radiology · 225d
Cleared Jan 10, 1997
SMART ADJUSTER (SA201)
K962239 · LXM
Sigma
Physical Medicine · 213d
Cleared Jan 10, 1997
PIXELL MRI SYSTEM
K962249 · LNH
General Medical Equipment Corp.
Radiology · 213d
Cleared Jan 10, 1997
S3 CARDIOPLEGIA CONTROL
K962320 · DTR
Stoeckert Instrumente
Cardiovascular · 207d
Cleared Jan 10, 1997
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
K962683 · HIF
Deknatel, Inc.
Obstetrics & Gynecology · 184d
Cleared Jan 10, 1997
FOTONA SKINLIGHT LASER SYSTEM
K962902 · GEX
Medical Laser Solutions
General & Plastic Surgery · 169d
Cleared Jan 10, 1997
STERILE SOFT-TEMP
K962983 · ILO
Adroit Medical Systems, Inc.
Physical Medicine · 162d
Cleared Jan 10, 1997
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
K962995 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 162d
Cleared Jan 10, 1997
OPTICAL DIGITIZER OPTION FOR VIEW POINT
K963221 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 147d
Cleared Jan 10, 1997
LUMEX AIR
K963674 · FNM
Lumex, Inc.
General Hospital · 119d
Cleared Jan 10, 1997
BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
K963950 · EXI
Bioderm, Inc.
Gastroenterology & Urology · 100d
Cleared Jan 10, 1997
3050 SPORT-NEB
K964078 · CAF
Medical Industries America, Inc.
Anesthesiology · 91d
Cleared Jan 10, 1997
AEROGEAR ASTHMA ACTION KIT
K964130 · BZH
Monaghan Medical Corp.
Anesthesiology · 87d
Cleared Jan 10, 1997
HYSTERO CO2-PNEU 2221
K964136 · HIG
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 87d