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
168721–168744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1979
ARICULATED TENSION DEVICE SYNTHES TEN
K792253 · HWN
Synthes (Usa)
Orthopedic · 28d
Cleared Dec 05, 1979
STANICOR, OMNI-STAN,MOD 333B,334A GAMMA
K792348 · DTX
Cordis Corp.
Cardiovascular · 16d
Cleared Dec 05, 1979
MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE
K792351 · GXY
Medtronic Vascular
Neurology · 16d
Cleared Dec 05, 1979
ANEROID SPHYMOMANOMETER
K792355 · DXQ
Abco Dealers, Inc.
Cardiovascular · 14d
Cleared Dec 05, 1979
MEDTRONIC MODEL 9407 TELETRACE TRANSMITT
K792359 · DXH
Medtronic Vascular
Cardiovascular · 14d
Cleared Dec 05, 1979
CARDIAC PACING ELECTRODE
K792379 · DTB
Medi-Dyne Instruments, Inc.
Cardiovascular · 9d
Cleared Dec 05, 1979
DEVO OXYGEN CONCENTRATOR, MODEL 955
K792385 · CAW
The Devilbiss Co.
Anesthesiology · 9d
Cleared Dec 05, 1979
IMPLANTABLE ENDOCARDIAL TINED ELECTRODE
K792387 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Dec 04, 1979
PROSTATIC ACID RADIOIMMUNOASSAY TEST
K791497 · JFH
Clinical Assays, Inc.
Chemistry · 123d
Cleared Dec 04, 1979
P-2 ULTRASONIC ARTERIOGRAPH
K792015 · DPT
D. E. Hokanson, Inc.
Cardiovascular · 60d
Cleared Dec 04, 1979
TEMPTRONIC 100 WATER BATH
K792060 · JTQ
Sybron Corp.
Immunology · 50d
Cleared Dec 04, 1979
DCG DATA TERMINAL
K792071
Del Mar Avionics
General Hospital · 15d
Cleared Dec 04, 1979
MODEL 1978 PRESSUROMETER III AMBULATORY
K792075 · DXN
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 04, 1979
MODEL 1981 PRESSUROMETER DATA ANALYSIS
K792077 · DSK
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 04, 1979
MODEL 656 ARRHYTHMIA ANALYZER
K792080 · DXG
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 04, 1979
CONPHAR BLOOD PRESSURE CUFFS
K792108 · DXQ
Conphar, Inc.
Cardiovascular · 40d
Cleared Dec 04, 1979
CONPHAR STETHSCOPE
K792112 · DQD
Conphar, Inc.
Cardiovascular · 40d
Cleared Dec 04, 1979
EMIT-BARBITURATE ASSAY
K792114 · DIS
Syva Co.
Toxicology · 39d
Cleared Dec 04, 1979
BONCHEK-SHILEY VEIN DISTENTION SYSTEM
K792134 · DWP
Shiley, Inc.
Cardiovascular · 43d
Cleared Dec 04, 1979
SANDARE HEMOGLOBIN CONTROLS
K792209 · JPK
Sandare Chemical Co., Inc.
Hematology · 32d
Cleared Dec 04, 1979
TEMPERATURE MONITOR (W/PROBE)
K792257 · FLL
Biotronex Laboratory, Inc.
General Hospital · 25d
Cleared Dec 04, 1979
RH VIEWBOX
K792306 · KSY
Tekpro
Hematology · 18d
Cleared Dec 04, 1979
NORM-TROL
K792310 · JPA
Helena Laboratories
Hematology · 18d
Cleared Dec 04, 1979
HELENA FACTOR VIII DEFICIENT SUB. PLASMA
K792335 · GGP
Helena Laboratories
Hematology · 15d