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
86833–86856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 22, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN...
K984317 · LGD
Zeus Scientific, Inc.
Microbiology · 50d
Cleared Jan 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
K984321 · CDD
Ortho-Clinical Diagnostics, Inc.
Immunology · 50d
Cleared Jan 22, 1999
DRAGER OXYLOG 2000
K984577 · CBK
Drager, Inc.
Anesthesiology · 30d
Cleared Jan 21, 1999
LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES
K982114 · LYY
M/S Midland Latex Products , Ltd.
General Hospital · 219d
Cleared Jan 21, 1999
ALLEGIANCE PORTA-WARM MATTRESS
K982652 · IMD
Allegiance Healthcare Corp.
Physical Medicine · 175d
Cleared Jan 21, 1999
GYRUS HYSTEROSCOPIC RESECTOSCOPE
K982771 · HIH
Gyrus Medical , Ltd.
Obstetrics & Gynecology · 167d
Cleared Jan 21, 1999
OVUM PICK-UP ASPIRATION NEEDLES
K983593 · MQE
Cook Ob/Gyn
Obstetrics & Gynecology · 100d
Cleared Jan 21, 1999
BISURE LAPAROSCOPIC BIPOLAR FORCEPS
K983743 · GEI
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Jan 21, 1999
MCAS (MODULAR CLIP APPLIER SYSTEM)
K983744 · DSS
Applied Medical Resources
Cardiovascular · 90d