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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
158401–158424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1982
MODEL WHO1 HEARING AID
K823285 · ESD
Panasonic Co. Div. Matsu Elec. Corp....
Ear, Nose, Throat · 25d
Cleared Nov 29, 1982
HEARING AID UE-10-H
K823366 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 29, 1982
LEG PREP HOLDER
K823391
Orthopedic Systems, Inc.
General & Plastic Surgery · 17d
Cleared Nov 29, 1982
FOREARM REDUCTION UNIT
K823392 · HST
Orthopedic Systems, Inc.
Neurology · 17d
Cleared Nov 29, 1982
FREE FLEX HEEL HEIGHT ADJUSTOR
K823396 · ISH
Orthopedic Systems, Inc.
Physical Medicine · 17d
Cleared Nov 29, 1982
ANATOMIC FRACTURE BRACE
K823397 · ITQ
Orthopedic Systems, Inc.
Physical Medicine · 17d
Cleared Nov 29, 1982
COVER LIMB
K823399 · IPM
Orthopedic Systems, Inc.
Physical Medicine · 17d
Cleared Nov 29, 1982
ARTHROSCOPIC LEG HOLDER
K823400
Orthopedic Systems, Inc.
General & Plastic Surgery · 17d
Cleared Nov 27, 1982
SARTOPHOR SYSTEM FOR ELECTROPHORESIS
K823132 · JJN
Sartorius Filters, Inc.
Chemistry · 33d
Cleared Nov 24, 1982
PRESS-O-TEST
K822102 · DXN
Medi-Swiss Corp.
Cardiovascular · 131d
Cleared Nov 24, 1982
MODEL 366-07 ADAPT AID LEAD ADAPTER
K822704 · DTD
Intermedics, Inc.
Cardiovascular · 78d
Cleared Nov 24, 1982
FLO CONTROL
K822891 · LDR
Dna Medical, Inc.
General Hospital · 57d
Cleared Nov 24, 1982
MODEL LS-85 & MEDEL 1828 LINESCAN VISCO
K822926
Honeywell, Inc.
Cardiovascular · 54d
Cleared Nov 24, 1982
HEART RATE & TEMP. MEASUREMENT SYSTEM
K822939 · FLL
Camino Laboratories, Inc.
General Hospital · 51d
Cleared Nov 24, 1982
MINGOCARD 7 & MINGOPHONE 7
K822983 · DSF
Siemens Corp.
Cardiovascular · 47d
Cleared Nov 24, 1982
COMPUTER INTERFACE MODULE CIM
K823035 · FRN
Y
General Hospital · 41d
Cleared Nov 24, 1982
JEOL MODEL #JTG-500M
K823041 · IYM
Jeol
Radiology · 41d
Cleared Nov 24, 1982
VAKUTAGE
K823080 · HHK
Weston, Copco, Inc.
Obstetrics & Gynecology · 36d
Cleared Nov 24, 1982
CAPIOX II
K823125 · DTZ
Terumo Medical Corp.
Cardiovascular · 30d
Cleared Nov 24, 1982
EXV VENOUS RESERVOIR BAG & HOLDER
K823205 · DTN
Extracorporeal Medical Specialities,...
Cardiovascular · 28d
Cleared Nov 24, 1982
MODEL 525 NEO-TRAK NEONATAL RECORDER
K823210 · DSF
Ge Medical Systems Information...
Cardiovascular · 27d
Cleared Nov 24, 1982
CKG 8800
K823215 · DSB
Cardio Kinetics, Inc.
Cardiovascular · 27d
Cleared Nov 24, 1982
COSMOS
K823220 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 23d
Cleared Nov 24, 1982
LIFESCOPE II/FOUR
K823249 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 23d