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
49921–49944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2010
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
K101255 · KWQ
Alphatec Spine, Inc.
Orthopedic · 78d
Cleared Jul 21, 2010
SCOUTPRO HEMOSTATIC VALVE
K101282 · DQY
Biotronik, Inc.
Cardiovascular · 76d
Cleared Jul 21, 2010
KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND...
K101596 · LZC
Kimberly-Clark
General Hospital · 43d
Cleared Jul 21, 2010
WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0
K101674 · MWI
Athena Gtx
Cardiovascular · 36d
Cleared Jul 21, 2010
GIRAFFE INCUBATOR
K101778 · FMZ
Ohmeda Medical
General Hospital · 26d
Cleared Jul 21, 2010
GIRAFFE OMNIBED
K101788 · FMZ
Ohmeda Medical
General Hospital · 26d
Cleared Jul 21, 2010
GIRAFFE AND PANDA WARMERS
K101804 · FMT
Ohmeda Medical, A Division of...
General Hospital · 23d
Cleared Jul 21, 2010
GLIDESHEATH
K102008 · DYB
Terumo Medical Corp.
Cardiovascular · 5d
Cleared Jul 20, 2010
SOPIX 2
K092329 · MUH
Sopro
Radiology · 350d
Cleared Jul 20, 2010
STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE)...
K100702 · FSY
Huot Instruments, LLC
General & Plastic Surgery · 130d
Cleared Jul 20, 2010
AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
K100802 · OVD
Aesculap Implant Systems, Inc.
Orthopedic · 120d
Cleared Jul 20, 2010
GALLERY LAMINOPLASTY FIXATION SYSTEM
K100805 · NQW
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 120d
Cleared Jul 20, 2010
CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
K100986 · MQV
Skeletal Kinetics, LLC
Orthopedic · 102d
Cleared Jul 19, 2010
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
K100031 · KHE
Ind Diagnostic, Inc.
Hematology · 194d
Cleared Jul 19, 2010
FIXPINE II SYSTEM
K100765 · MNI
Dio Medical Co., Ltd.
Orthopedic · 124d
Cleared Jul 19, 2010
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
K101095 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 19, 2010
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
K101455 · IYN
Medison Co., Ltd.
Radiology · 55d
Cleared Jul 19, 2010
COHEN CROSSOVER CATHETER
K101625 · DQO
Vascular Solutions, Inc.
Cardiovascular · 40d
Cleared Jul 16, 2010
SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
K092713 · IZL
Transamerican Medical Imaging
Radiology · 316d
Cleared Jul 16, 2010
ASTRASONIC SPIROMETER, MODEL 29-8000
K092813 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 305d
Cleared Jul 16, 2010
LASEMAR 800, 1000, 1500
K092860 · GEX
Eufoton S.R.L.
General & Plastic Surgery · 302d
Cleared Jul 16, 2010
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
K093784 · OPM
Zeus Scientific, Inc.
Microbiology · 219d
Cleared Jul 16, 2010
MEDIWORKS SLIT LAMP
K100439 · HJO
Shanghai Mediworks Precision...
Ophthalmic · 149d
Cleared Jul 16, 2010
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K100603 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 135d