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
146977–147000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1985
MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR
K853152 · JKA
Sherwood Medical Co.
Chemistry · 25d
Cleared Aug 23, 1985
OMNIMED I.V. SOLUTION ADMIN. SET
K853255 · FPA
Omni Intl., Inc.
General Hospital · 21d
Cleared Aug 23, 1985
CENTRIX RIBBON TUBES
K853282 · EID
Centrix, Inc.
Dental · 18d
Cleared Aug 23, 1985
TROCAR/CANNULA/SHEATH SET
K853337 · KOD
American Edwards Laboratories
Gastroenterology & Urology · 14d
Cleared Aug 23, 1985
DELTA TROL I & II
K853373 · JJT
Electro-Nucleonics Laboratories, Inc.
Chemistry · 11d
Cleared Aug 23, 1985
I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT
K853385 · FPA
Migada, Ltd.
General Hospital · 11d
Cleared Aug 23, 1985
QCA POTASSIUM TEST KIT
K853404 · CEJ
Bd Becton Dickinson Vacutainer...
Chemistry · 11d
Cleared Aug 22, 1985
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · DSP
Datascope Corp.
Cardiovascular · 196d
Cleared Aug 22, 1985
KINNET
K851875 · INY
Kinetic Concepts, Inc.
Physical Medicine · 115d
Cleared Aug 22, 1985
EXTERNAL MALE CATHETER
K852051 · KNX
Buffalo Medical Specialties Mfg., Inc.
Gastroenterology & Urology · 105d
Cleared Aug 22, 1985
PENOX PERFORMER WHEELCHAIR
K852109 · IOR
Penox Technologies, Inc.
Physical Medicine · 99d
Cleared Aug 22, 1985
AML PROXIMAL POROCOAT FEMORAL HIP
K852198 · LPH
Depuy, Inc.
Orthopedic · 94d
Cleared Aug 22, 1985
LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT
K852237 · LHL
Genetic Systems Corp.
Microbiology · 92d
Cleared Aug 22, 1985
MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT
K852388 · DQY
Quinton, Inc.
Cardiovascular · 73d
Cleared Aug 22, 1985
RIONET HEARING AID HB-69HT
K852453 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 73d
Cleared Aug 22, 1985
DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID
K852486 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 22, 1985
NEWPORT MEDIA TRANSFER CONTAINER
K852532 · KJA
Newport Bio Systems
Microbiology · 69d
Cleared Aug 22, 1985
ALL TERRAIN AMIGO
K852557 · INI
Amigo Sales, Inc.
Physical Medicine · 66d
Cleared Aug 22, 1985
POROUS APF/MODULAR FEMORAL COMPONENT
K852585 · JDI
Biomet, Inc.
Orthopedic · 65d
Cleared Aug 22, 1985
AMERICAN EDWARDS LABORATORIES FLEXISCOPE
K852759 · HRX
American Edwards Laboratories
Orthopedic · 55d
Cleared Aug 22, 1985
JAGUAR
K852809 · ITI
Inacare Corp.
Physical Medicine · 51d
Cleared Aug 22, 1985
RABBIT
K852810 · ITI
Invacare Corp.
Physical Medicine · 51d
Cleared Aug 22, 1985
RANGER-X
K852811 · ITI
Invacare Corp.
Physical Medicine · 51d
Cleared Aug 22, 1985
RANGER(II)
K852813 · ITI
Invacare Corp.
Physical Medicine · 51d