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
141337–141360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC
K864780 · FMF
Mac Lee Medical Products
General Hospital · 15d
Cleared Dec 23, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC
K864782 · FMF
Mac Lee Medical Products
General Hospital · 15d
Cleared Dec 23, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC
K864783 · FMF
Mac Lee Medical Products
General Hospital · 15d
Cleared Dec 22, 1986
NBP 488, TPR 488
K861856 · DXN
Siemens Medical Solutions USA, Inc.
Cardiovascular · 222d
Cleared Dec 22, 1986
AXION IV GOLDLINE SERIES
K862602 · GZJ
Ventura Medical Electronics
Neurology · 167d
Cleared Dec 22, 1986
HEALTHPHONE(TM)
K862668 · DXH
Carelink
Cardiovascular · 161d
Cleared Dec 22, 1986
NELLCOR MVP, MODEL N-1000
K862812 · DQA
Nellcor, Inc.
Anesthesiology · 151d
Cleared Dec 22, 1986
OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
K862837 · HSX
Osteonics Corp.
Orthopedic · 150d
Cleared Dec 22, 1986
M700 STRESS MONITOR
K863466 · DRT
Kone Instruments, Inc.
Cardiovascular · 105d
Cleared Dec 22, 1986
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494 · DRT
Advantage Medical Systems, Inc.
Cardiovascular · 104d
Cleared Dec 22, 1986
RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER
K863716
Futurecare Systems, Inc.
Cardiovascular · 90d
Cleared Dec 22, 1986
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · LCX
Hybritech, Inc.
Chemistry · 82d
Cleared Dec 22, 1986
BINAX STREP A
K863908 · GTZ
Binax, Inc.
Microbiology · 76d
Cleared Dec 22, 1986
KENZ-ECG 102
K863965 · DXK
Compumed, Inc.
Cardiovascular · 73d
Cleared Dec 22, 1986
SPECIFIC IGE FAST(TM) TEST II
K863967 · DHB
3M Company
Immunology · 73d
Cleared Dec 22, 1986
EM TENS WINDOW ELECTRODES
K864032 · GXY
Electromed Intl., Ltd.
Neurology · 68d
Cleared Dec 22, 1986
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS
K864409 · LER
Sclavo, Inc.
Toxicology · 42d
Cleared Dec 22, 1986
CHOICE
K864482 · HIS
Select Sources, Inc.
Obstetrics & Gynecology · 39d
Cleared Dec 22, 1986
TISSUE GRAM STAIN
K864531 · ICF
Sigma Diagnostics, Inc.
Pathology · 35d
Cleared Dec 22, 1986
FLUORESCENCE CONCENTRATION ANALYZER (FCA)
K864699 · JZT
Pandex Laboratories, Inc.
Immunology · 20d
Cleared Dec 22, 1986
BREMER HALO SYSTEM
K864746 · HAX
Bremer Orthopedics
Neurology · 17d
Cleared Dec 22, 1986
BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR
K864754
Pudenz-Schulte Medical Research Corp.
Neurology · 17d
Cleared Dec 19, 1986
OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM
K863668 · JWH
Osteonics Corp.
Orthopedic · 92d
Cleared Dec 18, 1986
OPHTHASONIC A-SCAN
K860757 · IYO
Teknar, Inc.
Radiology · 293d