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
138673–138696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800 · DEW
Abbott Laboratories
Immunology · 28d
Cleared Aug 12, 1987
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
K872834 · CZJ
Helena Laboratories
Immunology · 26d
Cleared Aug 12, 1987
ACCULITE
K872841 · IWE
Medical Alignment Systems
Radiology · 23d
Cleared Aug 12, 1987
A2J MZ 44 LASER LIGHT FOR POSITIONING
K872894 · IWE
Prometex, Inc.
Radiology · 20d
Cleared Aug 12, 1987
IMMUNO/SLE
K872910 · DHC
Immunostics Co., Inc.
Immunology · 19d
Cleared Aug 11, 1987
AMEBIASIS ELISA TEST KIT
K870318 · KHW
Lmd Laboratories
Microbiology · 195d
Cleared Aug 11, 1987
QUANTASCOPE
K870442 · DXR
Vital Science Corp.
Cardiovascular · 189d
Cleared Aug 11, 1987
MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
K871869 · EGJ
Life-Tech Intl., Inc.
Physical Medicine · 90d
Cleared Aug 11, 1987
PLAYTONE AUDIOMETER
K872042 · EWO
Sensory Aids Corp.
Ear, Nose, Throat · 76d
Cleared Aug 11, 1987
SIEMENS SILICONE IMPRESSION MATERIAL
K872152 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 68d
Cleared Aug 11, 1987
TRANSCOR RADIO-STETHOSCOPE MB
K872234 · DSH
Transcor, Inc.
Cardiovascular · 62d
Cleared Aug 11, 1987
LN 100 BREAST MARKER
K872319 · FTY
Instrumentation Industries, Inc.
General & Plastic Surgery · 55d
Cleared Aug 11, 1987
GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT
K872326 · JTW
Technology Management & Marketing, Inc.
Microbiology · 55d
Cleared Aug 11, 1987
ION TRAP DETECTOR (ITD)
K872464 · DOP
The Perkin-Elmer Corp.
Toxicology · 49d
Cleared Aug 11, 1987
DENTURE CLEANSERS
K872521 · JER
Dental Research Laboratories
Dental · 47d
Cleared Aug 11, 1987
IAFP X.L.D. AGAR
K872669 · JSI
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
IAFP MAC CONKEY AGAR
K872670 · JSH
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
IAFP BILE ESCULIN AZIDE AGAR
K872672 · JSI
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
I.A.F.P. C.D.C. ANAEROBIC SHEEP BLOOD AGAR W/P.E.A
K872673 · JSJ
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
IAFP COLUMBIA C.N.A. WITH 5% SHEEP BLOOD
K872674 · JSJ
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
IAFP MANNITOL NACL
K872675 · JSI
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
AFP MIDDLEBROOK 7H10 AGAR SLANT
K872676 · JSJ
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
IAFP HEKTOEN ENTERIC AGAR
K872680 · JSJ
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
IAFP C.D.C. ANAEROBIC AGAR W/5% SHEEP BLOOD
K872681 · JSG
I.A.F. Production, Inc.
Microbiology · 35d