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
152209–152232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1984
FILTRYZER HOLLOW FIBER ARTIFICIAL KID-
K831174 · KOC
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared Jun 22, 1984
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
K831175 · KOC
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared Jun 22, 1984
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
K831176 · KOC
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared Jun 22, 1984
GMP CIQ ELISA TEST KIT
K833275 · DAK
Gamma Medical Products, Inc.
Immunology · 275d
Cleared Jun 22, 1984
IN-THE-EAR HEARING AID MODEL
K833486 · ESD
Danavox, Inc.
Ear, Nose, Throat · 259d
Cleared Jun 22, 1984
SHEA MIDDLE EAR MICRODRILL
K833874 · ERL
Applied Research Corp.
Ear, Nose, Throat · 227d
Cleared Jun 22, 1984
SHEA FOOTPLATE MICRODRILL
K833875 · ERL
Applied Research Corp.
Ear, Nose, Throat · 227d
Cleared Jun 22, 1984
FLAME PHOTOMETERS
K834226 · JJO
Dr. Bruno Lange GmbH
Chemistry · 199d
Cleared Jun 22, 1984
EMIT D.A.U. URINE CANNABINOID CALIBRA
K834457 · DLJ
Syva Co.
Toxicology · 186d
Cleared Jun 22, 1984
TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC
K840023 · DRS
American Bentley
Cardiovascular · 169d
Cleared Jun 22, 1984
DIATRON EASYTEST BLOOD GLUCOSE MONI
K840484 · CGA
Medivix, Inc.
Chemistry · 137d
Cleared Jun 22, 1984
REFLOCHECK-S
K840962 · CGA
Boehringer Mannheim Corp.
Chemistry · 108d
Cleared Jun 22, 1984
BLOOD COLLECTION SET, STERILE, DISPOS.
K841187 · BRZ
Marbex, Inc.
General Hospital · 94d
Cleared Jun 22, 1984
DIAGNON FOLATE 125I RIA KIT
K841302 · CGN
Diagnon Corp.
Chemistry · 84d
Cleared Jun 22, 1984
ELECTROLYTE ANALYZER SERA-210
K841424 · JGS
Horiba Instruments, Inc.
Chemistry · 77d
Cleared Jun 22, 1984
NOVA STAT CONTROL LEVELS 1/2/3
K841452 · JJY
Nova Biomedical Corp.
Chemistry · 74d
Cleared Jun 22, 1984
CHANGES IN THE CHEMICAL COMP. OF 5
K841464 · JIX
Nova Biomedical Corp.
Chemistry · 102d
Cleared Jun 22, 1984
HEARING AID MODEL 440PPC
K841473 · ESD
Radioear Corp.
Ear, Nose, Throat · 74d
Cleared Jun 22, 1984
HEARING AID MODEL P500
K841474 · ESD
Radioear Corp.
Ear, Nose, Throat · 74d
Cleared Jun 22, 1984
HEARING AID MODEL M400
K841475 · ESD
Radioear Corp.
Ear, Nose, Throat · 74d
Cleared Jun 22, 1984
SCOTCHBOND LIGHT CURED DENTAL ADHES
K841550 · EBF
3M Company
Dental · 67d
Cleared Jun 22, 1984
OSSEOINTEGRATED FIXTURES-TISSUE INTEGR
K841551 · DZE
Bofors Nobelpharma, Inc.
Dental · 67d
Cleared Jun 22, 1984
ANA SENSITIVITY/SPECIFICITY CONTROL
K841776 · DHN
Behring Diagnostics, Inc.
Immunology · 53d
Cleared Jun 22, 1984
DENTURE CLEANSER
K841801 · EFT
Miracle Clean, Inc.
Dental · 52d