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
171049–171072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1978
MONITOR, NON-INVASIVE BLOOD PRESSURE
K782000 · DXN
Automated Screening Devices
Cardiovascular · 13d
Cleared Dec 04, 1978
PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS
K781000 · CEO
Abbott Laboratories
Chemistry · 172d
Cleared Dec 04, 1978
TEMPORARY CARDIAC PACING WIRE
K781002 · LDF
Ethicon, Inc.
Cardiovascular · 172d
Cleared Dec 04, 1978
ELISA SYSTME
K781269 · JJQ
Gilford Instrument Laboratories, Inc.
Chemistry · 133d
Cleared Dec 04, 1978
UNIPOPLAR ENDOCARDIAL LEADS
K781326 · DTB
American Technology, Inc.
Cardiovascular · 125d
Cleared Dec 04, 1978
AURO-BRUSH
K781351
Parker Laboratories, Inc.
Dental · 119d
Cleared Dec 04, 1978
OVALITH 10BP
K781377 · DXY
Coratomic, Inc.
Cardiovascular · 117d
Cleared Dec 04, 1978
ENDOCARDIAL BIPOLAR LEAD
K781456 · DTB
American Technology, Inc.
Cardiovascular · 103d
Cleared Dec 04, 1978
DIRECT ESTRIOL RIA KIT
K781546 · CGI
Immunalysis Corporation
Chemistry · 82d
Cleared Dec 04, 1978
DISPOSABLE LYMPHANGIOGRAM SET
K781575 · FPA
Instranetics, Inc.
Radiology · 81d
Cleared Dec 04, 1978
SURGICAL ASPIRATOR TIPS
K781592 · DYN
Henry Schein, Inc.
Dental · 77d
Cleared Dec 04, 1978
DENTAL WARM WATER IRRIGATING SYSTEM
K781594 · ECB
Rama Corp.
Dental · 80d
Cleared Dec 04, 1978
GE-700 INTRA ORAL X-RAY SYSTEM
K781630 · EAP
General Electric Co.
Radiology · 70d
Cleared Dec 04, 1978
X-RAY COLLIMATOR
K781675 · EHB
General X-Ray, Inc.
Radiology · 66d
Cleared Dec 04, 1978
AUROFIL
K781687 · EBF
Wallace A. Erickson & Co.
Dental · 62d
Cleared Dec 04, 1978
PEN, MARK-3 SKIN MARKING FOUNTAIN
K781694 · FZZ
Omega Mark-3 Pen Corp.
General & Plastic Surgery · 55d
Cleared Dec 04, 1978
BLOOD PRESSURE, DIGITAL MODEL #2153
K781701 · DSK
Sears, Roebuck & Co.
Cardiovascular · 55d
Cleared Dec 04, 1978
RULER, WECK SCOTT
K781715 · HOE
Edward Weck, Inc.
Ophthalmic · 60d
Cleared Dec 04, 1978
CHANGE IN STERILIZATION PROCEDURE
K781727 · GOY
Absorbent Cotton Co., Inc.
Chemistry · 54d
Cleared Dec 04, 1978
INHAMATIC 33
K781742 · IZD
Medimatic
Radiology · 48d
Cleared Dec 04, 1978
TUBING, AXIOM SILICONE PENROSE
K781749 · KDH
Axiom Medical, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 04, 1978
SERACON-SRI
K781757 · JIX
Bhp Diagnostix, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
SERACON-SRII
K781758 · JIX
Bhp Diagnostix, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
PAD, COOLING #27-999
K781764 · DTR
Cobe Laboratories, Inc.
Cardiovascular · 49d