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
144193–144216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1986
UROTOPO CATHETER
K861200 · KOD
Houston Biomedical, Inc.
Gastroenterology & Urology · 23d
Cleared Apr 23, 1986
MODEL ST HEARING AID
K861254 · ESD
Fine-Tune
Ear, Nose, Throat · 20d
Cleared Apr 23, 1986
FISCH DRILL IRRIGATOR
K861298 · KAR
Jedmed Instrument Co.
Ear, Nose, Throat · 16d
Cleared Apr 23, 1986
WHENEVER UNSCENTED REGULAR THIN MAXI-PADS
K861355 · HHD
Marcal Paper Mills, Inc.
Obstetrics & Gynecology · 13d
Cleared Apr 23, 1986
WHENEVER UNSCENTED SUPER THIN MAXI-PADS
K861356 · HHD
Marcal Paper Mills, Inc.
Obstetrics & Gynecology · 13d
Cleared Apr 23, 1986
WHENEVER UNSCENTED PANTY SHIELD
K861357 · HHD
Marcal Paper Mills, Inc.
Obstetrics & Gynecology · 13d
Cleared Apr 22, 1986
MODIFIED BRAIN ATLAS III
K854362 · GWE
Bio-Logic Systems Corp.
Neurology · 175d
Cleared Apr 22, 1986
GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR
K854499 · IZO
Gendex Corp.
Radiology · 161d
Cleared Apr 22, 1986
PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5
K854865 · DHB
Pharmacia, Inc.
Immunology · 144d
Cleared Apr 22, 1986
DIAMED MODELS 600, 900, 960, 964
K854953 · JAA
Diamed Division Ill. Tool Works, Inc.
Radiology · 133d
Cleared Apr 22, 1986
THABEST-IGE
K855053 · DHB
Visual Diagnostics, Inc.
Immunology · 126d
Cleared Apr 22, 1986
SERATEST RF (HEMAGGLUTINATION) KIT
K855221 · DHR
Hemagen Diagnostics, Inc.
Immunology · 113d
Cleared Apr 22, 1986
FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY
K860027 · DHB
Alerchek, Inc.
Immunology · 109d
Cleared Apr 22, 1986
MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902
K860100 · LHO
Victoreen, Inc.
Radiology · 102d
Cleared Apr 22, 1986
IV7200 AND IV7400 INFUSION PUMP
K860694 · FRN
Valleylab, Inc.
General Hospital · 56d
Cleared Apr 22, 1986
ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS
K861015 · FOZ
Acme United Corp.
General Hospital · 35d
Cleared Apr 22, 1986
LIC MOBILE TRANSPORT STRETCHERS
K861410 · FPO
Lada Intl., Inc.
General Hospital · 7d
Cleared Apr 21, 1986
SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE
K853089 · ELW
Psp Dental Co., Ltd.
Dental · 272d
Cleared Apr 21, 1986
CORDIA CMV-M
K853889 · LKQ
Cordis Corp.
Microbiology · 214d
Cleared Apr 21, 1986
MICRO-ELISA HLH TEST KIT MONOCLONAL
K860333 · CEP
Bioclinical Systems, Inc.
Chemistry · 82d
Cleared Apr 21, 1986
VISI-CHECK HLH TEST MONOCLONAL
K860334 · CEP
Bioclinical Systems, Inc.
Chemistry · 82d
Cleared Apr 21, 1986
MUREX (TM), SUDS (TM), HCG ASSAY
K860451 · LCX
Murex Corp.
Chemistry · 75d
Cleared Apr 21, 1986
BLOOD UREA NITROGEN (BUN) TESTCARD
K860543 · CDS
Ilex Corp.
Chemistry · 67d
Cleared Apr 21, 1986
LATEX R. TYPHI
K860557 · GPM
Health Research, Inc.
Microbiology · 66d