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
157321–157344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1983
FLOW-PAC ALBUMIN REAGENT
K830536 · CIX
Amresco, Inc.
Chemistry · 34d
Cleared Mar 24, 1983
FLOW-PAC CREATININE REAGENT SET
K830537 · CGX
Amresco, Inc.
Chemistry · 34d
Cleared Mar 24, 1983
FLOW-PAC TOTAL PROTEIN REAGENT SET
K830538 · CEK
Amresco, Inc.
Chemistry · 34d
Cleared Mar 24, 1983
AMRESCO UREA NITROGEN REAGENT SET
K830555 · CDQ
Amresco, Inc.
Chemistry · 29d
Cleared Mar 24, 1983
CREATININE
K830556 · CGX
Pointe Scientific, Inc.,
Chemistry · 29d
Cleared Mar 24, 1983
DISPOSABLE TEMP. PROBE & CABLE MODELS
K830561 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 29d
Cleared Mar 24, 1983
PERSONAL MEDICATION INFUSER
K830570 · FRN
Pacesetter Systems
General Hospital · 30d
Cleared Mar 24, 1983
BOTTLE ADAPTER
K830571 · KYX
Burron Medical Products, Inc.
General Hospital · 29d
Cleared Mar 24, 1983
MICROHEMATOCRIT READER
K830578 · JPI
Fisher Scientific Co., LLC
Hematology · 29d
Cleared Mar 24, 1983
TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR
K830586 · KNQ
Keymed, Inc.
Gastroenterology & Urology · 29d
Cleared Mar 24, 1983
CORNING FERRITIN 125I RADIOIMMUNOASSAY
K830591 · DBF
Corning Medical & Scientific
Chemistry · 28d
Cleared Mar 24, 1983
TITAN IMMUNO-FIX
K830594 · DEW
Helena Laboratories
Immunology · 28d
Cleared Mar 24, 1983
BABY CAP, ELECTRODE SET & BOARD ADAPTOR
K830597 · GXY
Precision Cap Systems
Neurology · 28d
Cleared Mar 24, 1983
EVOKED POTENTIAL CAP W/EVOKED POTENTIAL
K830598 · GXY
Precision Cap Systems
Neurology · 28d
Cleared Mar 24, 1983
LOCALIZING ELECTRODE
K830599 · GXY
Precision Cap Systems
Neurology · 28d
Cleared Mar 24, 1983
REFERENCE & MONITORING ELECTRODE
K830600 · GXY
Precision Cap Systems
Neurology · 28d
Cleared Mar 24, 1983
FOAMIES DIAPOS. FOAM RUBBER PADS
K830601 · GXY
Precision Cap Systems
Neurology · 28d
Cleared Mar 24, 1983
PRECISION CAP STRAPS
K830602 · GXY
Precision Cap Systems
Neurology · 28d
Cleared Mar 24, 1983
QUIK-SEP IGM ISOLATION SYSTEM
K830606 · DFT
Isolab, Inc.
Chemistry · 27d
Cleared Mar 24, 1983
USCI GRUNTZIG DILACA BALLOON DILATION
K830608 · LIT
C.R. Bard, Inc.
Cardiovascular · 27d
Cleared Mar 24, 1983
INFLATION DEVICE
K830609 · DXT
Interventional Medical, Inc.
Cardiovascular · 27d
Cleared Mar 24, 1983
RA SCREENING TEST
K830611 · DHR
Tago, Inc.
Immunology · 24d
Cleared Mar 24, 1983
CYTO-STAIN
K830625 · HJQ
Richard-Allan Medical Ind., Inc.
Pathology · 23d
Cleared Mar 24, 1983
CLARIFIER-RICHARD-ALLAN
K830627 · KEM
Richard-Allan Medical Ind., Inc.
Pathology · 23d