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
112729–112752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1993
MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15
K926571 · LNH
Medrad, Inc.
Radiology · 201d
Cleared Jul 20, 1993
FATHOM CMP-1000
K930051 · IYO
Fathom Ent., Inc.
Radiology · 195d
Cleared Jul 20, 1993
IQ TT4 ASSAY
K931295 · CDX
Becton Dickinson Advanced Diagnostics
Chemistry · 127d
Cleared Jul 20, 1993
SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY
K931498 · DKZ
Solarcare Technologies Corp,Inc.
Toxicology · 117d
Cleared Jul 20, 1993
3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE
K931605 · IWZ
3M Health Care, Ltd.
Radiology · 110d
Cleared Jul 20, 1993
QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY
K931666 · GGT
R&D Systems, Inc.
Hematology · 105d
Cleared Jul 20, 1993
SUNSCOPE 100
K931941 · JAA
Sunning Corp.
Radiology · 92d
Cleared Jul 20, 1993
RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P
K931942 · ESD
Resound Corp.
Ear, Nose, Throat · 92d
Cleared Jul 20, 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K932082 · JWY
Baxter Diagnostics, Inc.
Microbiology · 81d
Cleared Jul 20, 1993
MICROSURGICAL INSTRUMENTS
K932169 · GZX
American Russian Medical Services, Inc.
Neurology · 76d
Cleared Jul 19, 1993
CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR
K925444 · DYG
Ami-Med Corp.
Cardiovascular · 264d
Cleared Jul 19, 1993
LIQUID AMYLASE REAGENT SET
K930475 · JFJ
Pointe Scientific, Inc.,
Chemistry · 172d
Cleared Jul 19, 1993
URETERAL COMPRESSION DEVICE
K931268 · JAA
Bt Medical Co., Inc.
Radiology · 133d
Cleared Jul 19, 1993
STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY
K931516 · DIC
Solarcare Technologies Corp,Inc.
Toxicology · 115d
Cleared Jul 19, 1993
ADAMS SCIENTIFIC SENSITIVITY DISCS
K932052 · JTN
Adams Scientific, Inc.
Microbiology · 82d
Cleared Jul 16, 1993
SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)
K920966 · DQA
Aristo Medical Products, Inc.
Anesthesiology · 501d
Cleared Jul 16, 1993
CYTO PAK PAP SMEAR KIT
K923143 · HHT
International Medical Equipment...
Obstetrics & Gynecology · 382d
Cleared Jul 16, 1993
VARIOUS NON-STERILE CUSTOM TRAYS/KITS
K924690 · MCY
Surgipro Central, Inc.
General & Plastic Surgery · 302d
Cleared Jul 16, 1993
MEDIZIV SPINAL NEEDLE SET
K925831 · BSP
Medicia Medical Products
Anesthesiology · 242d
Cleared Jul 16, 1993
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
K930002 · LLM
Ortho Diagnostic Systems, Inc.
Microbiology · 193d
Cleared Jul 16, 1993
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
K930020 · LJN
Ortho Diagnostic Systems, Inc.
Microbiology · 193d
Cleared Jul 16, 1993
URETERAL CATHETER
K930483 · EYB
Surgitek
Gastroenterology & Urology · 168d
Cleared Jul 16, 1993
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
K931495 · LLL
Helix Diagnostics, Inc.
Immunology · 113d
Cleared Jul 16, 1993
IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
K931806 · CZP
The Binding Site, Ltd.
Immunology · 95d