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
165409–165432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1981
GALVANATOR 725
K810057 · IPF
Avratronics Corp.
Physical Medicine · 10d
Cleared Jan 23, 1981
CURVED SHERMAN BONE PLATE
K810061 · HRS
Howmedica Corp.
Orthopedic · 10d
Cleared Jan 22, 1981
SIRECUST 400 SYSTEM PATIENT MONITORING
K802113 · DPS
Analogic Corp.
Cardiovascular · 141d
Cleared Jan 22, 1981
HP MODEL 4710A ECG TRANSMITTER
K802717 · DXH
Hewlett-Packard Co.
Cardiovascular · 83d
Cleared Jan 22, 1981
SEMI-OVAL MODULAR SUNTANNING BOOTH
K802756 · LEJ
Tannhut
Radiology · 78d
Cleared Jan 22, 1981
TERUMO HOLLOW FIBER OXYGENATOR
K802970 · DTZ
Terumo America, Inc.
Cardiovascular · 62d
Cleared Jan 22, 1981
DIASONICS SMALL PARTS SCANNER
K802979 · IYN
Diasonics, Inc.
Radiology · 62d
Cleared Jan 22, 1981
INTERPULSE MEMBRANE OXYGENATION SYSTEM
K803003 · DTZ
Extracorporeal Medical Specialities,...
Cardiovascular · 57d
Cleared Jan 22, 1981
PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.
K803032 · KPQ
Pfizer Medical Systems, Inc.
Radiology · 52d
Cleared Jan 22, 1981
SUNMAKER (SUN TANNING BED)
K803090 · LEJ
Sunmaker, Inc.
Radiology · 45d
Cleared Jan 22, 1981
TECHNY REX 3000 MOBILE X-RAY UNIT
K803103 · IZL
Tecnomed, Inc.
Radiology · 44d
Cleared Jan 22, 1981
TILTING IMAGING TABLE #846T
K803120 · KXJ
Quinton, Inc.
Radiology · 42d
Cleared Jan 22, 1981
SIDOS U.
K803124 · KPQ
Siemens Corp.
Radiology · 42d
Cleared Jan 22, 1981
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274
K803197 · DXY
Telectronics, Inc.
Cardiovascular · 37d
Cleared Jan 22, 1981
CSG-FLOW CONTROL VALVE
K803257 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 30d
Cleared Jan 22, 1981
CRITERION II RHYTHM PROFILE MONITOR
K803315 · DXH
Dart Medical Equipment
Cardiovascular · 23d
Cleared Jan 22, 1981
PEDIATRIC ARTERIAL BLOOD FILTER
K810068 · DTM
Delta Medical Industries
Cardiovascular · 9d
Cleared Jan 21, 1981
MARK V DUPLEX ULTRASONIC SCAN SYS.
K802438 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 107d
Cleared Jan 21, 1981
IMMUNOREACTIVE ESTRIOL RIA KIT
K802754 · CGI
Microanalytic Research, Inc.
Chemistry · 79d
Cleared Jan 21, 1981
ACRODISC FILTER ASSEMBLY
K802765 · FPB
Gelman Sciences, Inc.
Chemistry · 78d
Cleared Jan 21, 1981
NORMAL AND ELEVATED CONTROL FOR GLYCO.
K803186 · LCP
Applied Clinical Research Laboratories
Chemistry · 36d
Cleared Jan 21, 1981
IRRIGATION SET W/BULB SYRINGE
K803200 · KYZ
Walpak Co.
General Hospital · 35d
Cleared Jan 21, 1981
IRRIGATION PISTON
K803204 · FMF
Walpak Co.
General Hospital · 35d
Cleared Jan 21, 1981
SUCTION PROBE
K803206 · JOL
Bemis Health Care
General Hospital · 35d