FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87337–87360 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1999
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
K984288 · DLZ
Ortho-Clinical Diagnostics, Inc.
Toxicology · 56d
Cleared Jan 26, 1999
ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01
K990149 · JJY
Bio-Rad
Chemistry · 7d
Cleared Jan 26, 1999
ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01
K990150 · JJY
Bio-Rad
Chemistry · 7d
Cleared Jan 25, 1999
VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
K981954 · NRQ
Healthline Implants, Inc.
Dental · 235d
Cleared Jan 25, 1999
FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
K982264 · MKJ
Survivalink Corp.
Cardiovascular · 210d
Cleared Jan 25, 1999
PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM,...
K982432 · KLW
Tinnitus Treatment Centers, Inc.
Ear, Nose, Throat · 196d
Cleared Jan 25, 1999
BLADDERMANAGER PCI 5000 MODEL 1002
K982568 · ITX
Diagnostic Ultrasound Corp.
Radiology · 186d
Cleared Jan 25, 1999
ELECTROSURGICAL DISPERSIVE ELECTRODE
K983782 · GEI
Conmedcorp
General & Plastic Surgery · 90d
Cleared Jan 25, 1999
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
K983832 · ETY
Idem (Int'L Dist. of Electronics For...
Ear, Nose, Throat · 87d
Cleared Jan 25, 1999
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE...
K983905 · LMC
Eastman Kodak Company
Radiology · 83d
Cleared Jan 25, 1999
RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
K984045 · DHR
Kamiya Biomedical Co.
Immunology · 73d
Cleared Jan 25, 1999
ENTAXIS NASAL PACKING
K984069 · EMX
Les Laboratorires Brothier, S.A.
Ear, Nose, Throat · 70d
Cleared Jan 25, 1999
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K984127 · LYY
Kilang Barangan Getah Dioh
General Hospital · 68d
Cleared Jan 25, 1999
IMATION TRIMATIC DIGITAL SYSTEM
K984252 · LMA
Imation Corp.
Radiology · 59d
Cleared Jan 25, 1999
MEDRAD PHASED ARRAY NEUROVASCULAR COIL
K984257 · MOS
Medrad, Inc.
Radiology · 56d
Cleared Jan 25, 1999
FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS
K984273 · MVN
Ciba Vision Corporation
Ophthalmic · 56d
Cleared Jan 25, 1999
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
K984274 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 56d
Cleared Jan 25, 1999
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)
K984605 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 28d
Cleared Jan 25, 1999
ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10
K990017 · JJY
Bio-Rad
Chemistry · 21d
Cleared Jan 25, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS
K990061 · JJX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 17d
Cleared Jan 22, 1999
6004 NIBP MONITOR WITH TEMPERATURE
K983796 · DXN
Bci Intl., Inc.
Cardiovascular · 87d
Cleared Jan 22, 1999
EMS PEEP VALVES- ADJUSTABLE
K983920 · BYE
Engineered Medical Systems
Anesthesiology · 79d
Cleared Jan 22, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
K984181 · LFY
Zeus Scientific, Inc.
Microbiology · 60d
Cleared Jan 22, 1999
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
K984232 · DJG
Syva Co.
Toxicology · 58d