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
43057–43080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2012
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
K122811 · DTL
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 11, 2012
TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X...
K121083 · OZT
Loma Vista Medical
Cardiovascular · 184d
Cleared Oct 11, 2012
PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT...
K121379 · CBK
Airon Corporation
Anesthesiology · 156d
Cleared Oct 11, 2012
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
K121543 · KWT
Zimmer, Inc.
Orthopedic · 139d
Cleared Oct 11, 2012
FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND...
K121591 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 133d
Cleared Oct 11, 2012
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
K121679 · NBW
Roche Diagnostics
Chemistry · 126d
Cleared Oct 11, 2012
WIRELESS THERMOMETER
K121696 · FLL
Raling Medical Company
General Hospital · 126d
Cleared Oct 11, 2012
ESA620 ELECTRICAL SAFETY ANALYZER
K121722 · DRT
Fluke Biomedical
Cardiovascular · 121d
Cleared Oct 11, 2012
WECK REUSABLE OBTURATOR
K121796 · GCJ
Teleflexmedical, Inc.
General & Plastic Surgery · 114d
Cleared Oct 11, 2012
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA...
K121883 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 105d
Cleared Oct 11, 2012
VISUALIF CHALLENGING ACCESS PLATE
K122168 · OVD
Spine Smith Partners L.P.
Orthopedic · 80d
Cleared Oct 11, 2012
FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA...
K122178 · LOX
Ostial Corporation
Cardiovascular · 80d
Cleared Oct 11, 2012
CAPSURE(R) PS SYSTEM
K122233 · MNI
Spine Wave, Inc.
Orthopedic · 77d
Cleared Oct 11, 2012
APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT...
K122463 · MBI
Cayenne Medical, Inc.
Orthopedic · 59d
Cleared Oct 11, 2012
LIFEPAK 1000 DEFIBRILLATOR
K122600 · MKJ
Physio-Control, Inc.
Cardiovascular · 45d
Cleared Oct 11, 2012
PROFEMUR Z REVISION HIP STEM
K122778 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Oct 11, 2012
CXI SUPPORT CATHETER
K122796 · KRA
Cook, Inc.
Cardiovascular · 29d
Cleared Oct 11, 2012
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
K122798 · LPH
Exactech, Inc.
Orthopedic · 29d
Cleared Oct 11, 2012
ARCHON ANTERIOR CERVICAL PLATE SYSTE,
K122910 · KWQ
Nu Vasive, Incorporated
Orthopedic · 20d
Cleared Oct 10, 2012
NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
K112826 · MUD
Moor Instruments, Ltd.
Cardiovascular · 378d
Cleared Oct 10, 2012
BLUE SUI SLING
K121754 · OTN
Boston Scientific Corp
Gastroenterology & Urology · 118d
Cleared Oct 10, 2012
FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
K122504 · LPH
United Orthopedic Corporation
Orthopedic · 55d
Cleared Oct 09, 2012
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
K112837 · JDR
Vilex, Inc.
Orthopedic · 377d
Cleared Oct 09, 2012
ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE
K121076 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 183d