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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
146449–146472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1985
POLYFLEX IMPLANTABLE PACING LEAD-476-07
K853521 · DTB
Intermedics, Inc.
Cardiovascular · 104d
Cleared Dec 04, 1985
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT
K853695 · GQG
Viromed Laboratories, Inc.
Microbiology · 91d
Cleared Dec 04, 1985
TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804
K853718 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 90d
Cleared Dec 04, 1985
TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410
K853719 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 90d
Cleared Dec 04, 1985
EXPLORER
K853850 · DTB
Mansfield Scientific, Inc.
Cardiovascular · 79d
Cleared Dec 04, 1985
POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD
K854071 · DTB
Intermedics, Inc.
Cardiovascular · 61d
Cleared Dec 04, 1985
ARRHYTHMIA REVIEW STATION
K854136 · DXG
Marquette Electronics, Inc.
Cardiovascular · 55d
Cleared Dec 04, 1985
IN-VITRO TEST DETERMINATION OF TOBRAMYCIN
K854184 · KLB
Clinical Data, Inc.
Toxicology · 50d
Cleared Dec 04, 1985
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD
K854220 · DTB
Pacesetter Systems
Cardiovascular · 47d
Cleared Dec 04, 1985
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
K854261 · DTL
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 42d
Cleared Dec 04, 1985
KONTRON DEFIBRILLATOR 7501
K854307 · LDD
Kontron Instruments, Inc.
Cardiovascular · 40d
Cleared Dec 04, 1985
ACS INDEFLATOR (MODIFICATION)
K854310 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d
Cleared Dec 04, 1985
HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS
K854376 · JPA
Hemotec, Inc.
Hematology · 35d
Cleared Dec 04, 1985
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
K854377 · JOX
Hemotec, Inc.
Hematology · 35d
Cleared Dec 04, 1985
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD
K854405 · DTB
Pacesetter Systems
Cardiovascular · 33d
Cleared Dec 04, 1985
CK(OPTIMIZED) REAGENT
K854501 · CGS
Sigma Diagnostics, Inc.
Chemistry · 22d
Cleared Dec 03, 1985
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
K851365 · DXY
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 242d
Cleared Dec 03, 1985
PMA PRESSURE MONITOR
K852824 · CAP
Ferguson Medical
Anesthesiology · 155d
Cleared Dec 03, 1985
TMA TEMPERATURE MONITOR
K852825 · FLL
Ferguson Medical
General Hospital · 155d
Cleared Dec 03, 1985
AN PRESSURE MONITOR
K852826 · CAP
Ferguson Medical
Anesthesiology · 154d
Cleared Dec 03, 1985
L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION
K853099 · DTL
L.O.N. Research, Inc.
Cardiovascular · 133d
Cleared Dec 03, 1985
MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)
K853136 · MAV
E.A. Fischione Instrument Mfg.
Cardiovascular · 130d
Cleared Dec 03, 1985
CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
K853383 · DYG
Webster Laboratories, Inc.
Cardiovascular · 113d
Cleared Dec 03, 1985
TENS CONDUCTIVE MEDIA PAD
K853633 · GXY
Alternative Design Systems, Inc.
Neurology · 95d