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
50113–50136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2010
MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM
K093104 · MNI
Medyssey Co, Ltd.
Orthopedic · 267d
Cleared Jun 25, 2010
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
K093196 · FTL
Cousin Biotech Sas
General & Plastic Surgery · 259d
Cleared Jun 25, 2010
MOBIVISION
K100001 · MQB
Almana Medical Imaging
Radiology · 172d
Cleared Jun 25, 2010
OCTO
K100045 · GCJ
Dalim Surgnet Corporation
General & Plastic Surgery · 168d
Cleared Jun 25, 2010
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
K100214 · ODP
Medtronic Sofamor Danek
Orthopedic · 151d
Cleared Jun 25, 2010
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV,...
K100399 · GZJ
Well-Life Healthcare Limited
Neurology · 129d
Cleared Jun 25, 2010
MYOSCIENCE CRYO-TOUCH
K100447 · GXH
Myoscience, Inc.
Neurology · 128d
Cleared Jun 25, 2010
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND...
K100694 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 106d
Cleared Jun 25, 2010
REPROCESSED PINS
K100707 · NDM
Sterilmed, Inc.
Orthopedic · 105d
Cleared Jun 25, 2010
STRYKER KNIFELIGHT
K100884 · FTD
Howmedica Osteonics Corp.
General & Plastic Surgery · 87d
Cleared Jun 25, 2010
MYLABTWICE, MODEL 6200
K100931 · IYN
Esaote, S.P.A.
Radiology · 81d
Cleared Jun 25, 2010
ZURA TEE SYSTEM WITH CLARITEE PROBE
K100989 · IYN
Imacor, Inc.
Radiology · 77d
Cleared Jun 25, 2010
SHIKANI SPEAKING VALVE
K100995 · JOH
Shikani Medical, LLC
Anesthesiology · 77d
Cleared Jun 25, 2010
CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
K101018 · FZP
Cardica, Inc.
General & Plastic Surgery · 73d
Cleared Jun 25, 2010
Z.ONE ULTRA ULTRASOUND SYSTEM
K101091 · IYN
Zonare Medical Systems, Inc.
Radiology · 67d
Cleared Jun 25, 2010
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K101431 · DTK
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Jun 25, 2010
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
K101639 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 15d
Cleared Jun 25, 2010
SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
K101671 · GCJ
Teleflexmedical, Inc.
General & Plastic Surgery · 11d
Cleared Jun 24, 2010
STERN'S S250 NORDAM
K092917 · EIA
Cefla S.C.
Dental · 275d
Cleared Jun 24, 2010
PRUCLAIR NONSTEROIDAL CREAM
K093156 · FRO
Prugen IP Holdings, Inc.
General & Plastic Surgery · 261d
Cleared Jun 24, 2010
PR CREAM
K093159 · FRO
Prugen IP Holdings, Inc.
General & Plastic Surgery · 261d
Cleared Jun 24, 2010
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE...
K093357 · JIT
Diamond Diagnostics, Inc.
Chemistry · 239d
Cleared Jun 24, 2010
MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS
K093643 · NHA
Nobel Biocare AB
Dental · 211d
Cleared Jun 24, 2010
ECHOBRIGHT
K093662 · CAZ
Life-Tech, Inc.
Anesthesiology · 211d