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

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175,820 results
145057–145080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1986
TRACHEOBRONCHIAL SUCTION CATHETER
K860802 · BSY
Sheridan Catheter Corp.
Anesthesiology · 29d
Cleared Apr 02, 1986
VISTA INTERFACE SYSSTEM
K860844 · BZC
Vacumetrics, Inc.
Anesthesiology · 27d
Cleared Apr 02, 1986
DISPOSABLE HEATED WIRE LOOPS 48 AND 72
K860941 · BZE
Intec Medical, Inc.
Anesthesiology · 21d
Cleared Apr 02, 1986
CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
K861019 · EAK
Phase One Disign Co.
Radiology · 15d
Cleared Apr 02, 1986
BIOPSY ADAPTER H4222W
K861050 · GDF
General Electric Co.
General & Plastic Surgery · 14d
Cleared Apr 02, 1986
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
K861088 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 12d
Cleared Apr 01, 1986
HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS
K855150 · LKX
Hpk International, Inc.
Gastroenterology & Urology · 96d
Cleared Apr 01, 1986
MODULAR PRESS FIT (MPF) STEM
K855200 · JDI
Depuy, Inc.
Orthopedic · 95d
Cleared Apr 01, 1986
CONICAL COLLAR HIP PROSTHESIS POROUS COATED
K860002 · JDI
Kirschner Medical Corp.
Orthopedic · 89d
Cleared Apr 01, 1986
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING
K860455 · BZQ
Oxford Medilog, Inc.
Anesthesiology · 55d
Cleared Apr 01, 1986
UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)
K860535 · CAT
Andover Medical, Inc.
Anesthesiology · 48d
Cleared Apr 01, 1986
ESOPHAGEAL STETHOSCOPE
K860558 · BZW
Sharn, Inc.
Anesthesiology · 46d
Cleared Apr 01, 1986
MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06
K860761 · LMC
Lenzar Optics Corp.
Radiology · 32d
Cleared Apr 01, 1986
SIREGRAPH D
K860913 · IXR
Siemens Medical Solutions USA, Inc.
Radiology · 21d
Cleared Apr 01, 1986
OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER
K861166 · CAN
Victor
Anesthesiology · 4d
Cleared Apr 01, 1986
NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
K861170 · BSZ
Draeger Medical, Inc.
Anesthesiology · 4d
Cleared Mar 31, 1986
UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762
K852973 · DXY
Ela Medical, Inc.
Cardiovascular · 259d
Cleared Mar 31, 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669 · DSI
Hewlett-Packard Co.
Cardiovascular · 209d
Cleared Mar 31, 1986
SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER
K854319 · LIT
Shiley, Inc.
Cardiovascular · 154d
Cleared Mar 31, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
K854830 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 118d
Cleared Mar 31, 1986
VALVOKIT
K854831 · DYB
Novamed Products, Inc.
Cardiovascular · 118d
Cleared Mar 31, 1986
CUP MONITORING KIT CVPK-14
K854984 · DQY
Medical Components, Inc.
Cardiovascular · 109d
Cleared Mar 31, 1986
NONINVASIVE TEMP. PACEMAKER NTP-1000
K855015 · DRO
Zmi Corp.
Cardiovascular · 105d
Cleared Mar 31, 1986
DEFIB-PADS
K855082 · LDD
Conmedcorp
Cardiovascular · 102d