Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158161–158184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1983
OMED IDENT-I-BAND
K830484
Omega-Med Intl., Inc.
General & Plastic Surgery · 37d
Cleared Mar 24, 1983
NOVA 8 IONIZED CALCIUM/PH ANALYZER
K830502 · JFP
Nova Biomedical Corp.
Chemistry · 36d
Cleared Mar 24, 1983
PRECISION EEG CAP W/ELECTRODE SET AND
K830521 · GXY
Precision Cap Systems
Neurology · 35d
Cleared Mar 24, 1983
HENKE JECT PRESSURE SYRINGE
K830524 · EJI
Smith & Nephew, Mpl Division
Dental · 35d
Cleared Mar 24, 1983
BIOFEEDBACK-TRAINING INSTRUMENT
K830529 · HCC
Relaxomat, Inc.
Neurology · 34d
Cleared Mar 24, 1983
FLOW-PAC ALKALINE PHOSPHATE REAGENT SET
K830535 · CJF
Amresco, Inc.
Chemistry · 34d
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