FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122449–122472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1991
VIDEO ANNOTATOR MODEL PK2310
K910384 · JAA
Perkins Mfg. Co.
Radiology · 77d
Cleared Apr 16, 1991
RESPI-PAK RT-PAK
K910452 · BZG
Cns, Inc.
Anesthesiology · 74d
Cleared Apr 16, 1991
SAFETYSNAP SAFETY SYRINGE
K910520 · FMF
U.S. Medical Instruments, Inc.
General Hospital · 69d
Cleared Apr 16, 1991
MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
K910716 · FCX
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 55d
Cleared Apr 16, 1991
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · KDI
Abbott Laboratories
Gastroenterology & Urology · 34d
Cleared Apr 16, 1991
CHLORIDE REAGENT
K911297 · CHJ
Intersect Systems, Inc.
Chemistry · 22d
Cleared Apr 16, 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K
K911339 · IZO
Shimadzu Medical Systems
Radiology · 21d
Cleared Apr 16, 1991
OPUS FSH
K911409 · CGJ
Pb Diagnostic Systems, Inc.
Toxicology · 15d
Cleared Apr 16, 1991
LATEX EXAMINATION GLOVES (HYPOALLERGENIC)
K911447 · LYY
Aladan Corp.
General Hospital · 39d
Cleared Apr 16, 1991
MULTIPLE BIOPSY DEVICE-MBX
K911448 · FCK
Triton Technology, Inc.
Gastroenterology & Urology · 32d
Cleared Apr 16, 1991
REP SPE PLUS (ACID BLUE) SYSTEM
K911468 · CEF
Helena Laboratories
Chemistry · 13d
Cleared Apr 15, 1991
PERIOGARD(R) PERIOPEN
K901955 · EFS
Colgate-Palmolive Co.
Dental · 349d
Cleared Apr 15, 1991
LUXAR MODEL LX-20 CO2 LASER
K904068 · GEX
Luxar Corp.
General & Plastic Surgery · 227d
Cleared Apr 15, 1991
ZIRCONIA CERAMIC MODULAR HEADS
K905687 · LZO
Biomet, Inc.
Orthopedic · 117d
Cleared Apr 15, 1991
MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
K910167 · GCY
Microbio-Medics, Inc.
General & Plastic Surgery · 90d
Cleared Apr 15, 1991
TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T
K910268 · ITX
Hitachi Medical Corp.
Radiology · 90d
Cleared Apr 15, 1991
AHL, ITE MODEL AMERICAN
K910325 · ESD
Bob Bare Hearing Aid Repair
Ear, Nose, Throat · 81d
Cleared Apr 15, 1991
HEMOCARD-AS
K910430 · GHM
Isolab, Inc.
Hematology · 73d
Cleared Apr 15, 1991
TYCERAMIC
K910569 · ELL
Jeneric/Pentron, Inc.
Dental · 63d
Cleared Apr 15, 1991
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT
K911209 · ESD
Phonak, Inc.
Ear, Nose, Throat · 27d
Cleared Apr 15, 1991
LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015
K911355 · LJT
Strato Medical Corp.
General Hospital · 53d
Cleared Apr 12, 1991
UTAK LABORATORIES TOXICOLOGY CONTROL
K903061 · LAS
Utak Laboratories, Inc.
Toxicology · 277d
Cleared Apr 12, 1991
CVIS INSIGHT IMAGING CATHETER
K904618 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 183d
Cleared Apr 12, 1991
BC 1206 IMPLANT - INSERT TYPE
K904705 · DZE
Minimatic Implant Technology
Dental · 178d