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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
116257–116280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1992
QUADRATURE SHOULDER CONTOUR COIL
K920227 · LNH
Magnetic Research, Inc.
Radiology · 220d
Cleared Aug 24, 1992
COWBOY II
K920308 · JOW
Kinetic Concepts, Inc.
Cardiovascular · 214d
Cleared Aug 24, 1992
GAC THUMB-SUCKING CONTROL APPLIANCE
K920850 · DZC
Gac Intl., Inc.
Dental · 181d
Cleared Aug 24, 1992
USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT
K920980 · DQO
C.R. Bard, Inc.
Cardiovascular · 175d
Cleared Aug 24, 1992
TOUCH N' HEAT, MODIFICATION
K921604 · EKZ
Analytic Technology
Dental · 150d
Cleared Aug 24, 1992
DIGOXIN COATED TUBE RIA
K922353 · LCS
Monobind
Toxicology · 97d
Cleared Aug 24, 1992
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000
K922411 · LMC
Eastman Kodak Company
Radiology · 95d
Cleared Aug 24, 1992
MODEL 105 VENTILATOR, MODIFICATION
K922477 · CBK
Infrasonics Corp.
Anesthesiology · 89d
Cleared Aug 24, 1992
SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER
K922492 · CAH
Specialty Packaging Producs, Inc.
General Hospital · 89d
Cleared Aug 24, 1992
WOUND DRESSING
K922540 · KMF
Les Laboratorires Brothier, S.A.
General & Plastic Surgery · 87d
Cleared Aug 24, 1992
STANDARD IMAGING HDR 1000 ION CHAMBER
K922554 · JAQ
Standard Imaging, Inc.
Radiology · 87d
Cleared Aug 24, 1992
GROUP AUDITORY TRAINING SYSTEM
K922720 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 80d
Cleared Aug 24, 1992
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
K922913 · LBZ
Syva Co.
Chemistry · 68d
Cleared Aug 24, 1992
EMIT 2000 PROCAINAMIDE CALIBRATORS
K922914 · LAR
Syva Co.
Toxicology · 68d
Cleared Aug 24, 1992
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
K922915 · LAN
Syva Co.
Toxicology · 68d
Cleared Aug 24, 1992
BARD MARLEX MESH DART
K922916 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 68d
Cleared Aug 24, 1992
MILES POTASSIUM METHOD
K923038 · CEM
Heraeus Kulzer, Inc.
Chemistry · 66d
Cleared Aug 24, 1992
MILES URINE CREATININE METHOD
K923039 · CGX
Heraeus Kulzer, Inc.
Chemistry · 66d
Cleared Aug 24, 1992
AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY
K923314 · JXO
Serex, Inc.
Toxicology · 48d
Cleared Aug 24, 1992
VOICEWAVE
K923924 · ESD
Personal Sound Technologies, Inc.
Ear, Nose, Throat · 19d
Cleared Aug 21, 1992
DOSCOPE AND ACESSORIES
K920224 · FBN
Applied Laparoscopy
Gastroenterology & Urology · 217d
Cleared Aug 21, 1992
PERMAMESH HYDROXYLAPATITE MATRIX
K921468 · LYC
Ceramed Corp.
Dental · 147d
Cleared Aug 20, 1992
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K914959 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 289d
Cleared Aug 20, 1992
MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM
K920212 · LJZ
Shared Systems, Inc.
Microbiology · 217d