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
49777–49800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2010
MISSION SALIVA ALCOHOL TEST STRIP
K093879 · DIC
ACON Laboratories, Inc.
Toxicology · 231d
Cleared Aug 06, 2010
BUSSE EPIDURAL CATHETER KIT
K093920 · BSO
Busse Hospital Disposables
Anesthesiology · 227d
Cleared Aug 06, 2010
ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I
K094021 · NEY
Microsulis Medical Limited
General & Plastic Surgery · 219d
Cleared Aug 06, 2010
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0
K100376 · MSX
Earlysense, Ltd.
Cardiovascular · 175d
Cleared Aug 06, 2010
LANX SPINAL FIXATION SYSTEM
K100935 · NKB
Lanx, Inc.
Orthopedic · 123d
Cleared Aug 06, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100963 · LYZ
Hebei Shenzichen Plastic & Rubber...
General Hospital · 121d
Cleared Aug 06, 2010
SEILER COLPOSCOPE, MODELS 935, 955 AND 985
K101141 · HEX
Seiler Precision Microscopes
Obstetrics & Gynecology · 106d
Cleared Aug 06, 2010
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
K101508 · LHN
Ion Beam Applications S.A.
Radiology · 66d
Cleared Aug 06, 2010
HEADWAY 17 ADVANCED MICROCATHETER
K101542 · DQY
MicroVention, Inc.
Cardiovascular · 64d
Cleared Aug 06, 2010
STINGRAY ORIENTING BALLOON CATHETER
K101591 · DQY
Bridgepoint Medical
Cardiovascular · 60d
Cleared Aug 06, 2010
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
K101595 · LZA
Better Care Plastic Technology Cp., Ltd.
General Hospital · 59d
Cleared Aug 06, 2010
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
K101647 · DQY
Avinger, Inc.
Cardiovascular · 56d
Cleared Aug 06, 2010
OCCLUSION BALLOON CATHETER MODEL OBC
K101877 · DQY
Cook, Inc.
Cardiovascular · 31d
Cleared Aug 06, 2010
VASOPRESS SUPREME MINI MODEL VP500DM
K101915 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 28d
Cleared Aug 06, 2010
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
K102001 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 22d
Cleared Aug 06, 2010
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S
K102022 · DQY
Avinger, Inc.
Cardiovascular · 18d
Cleared Aug 06, 2010
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K102065 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Aug 06, 2010
ENDOSCOPIC CLIP SYSTEM
K102081 · FZP
Aesculap, Inc.
General & Plastic Surgery · 11d
Cleared Aug 06, 2010
TISSU TRANS FILTRON SYRINGE FILL
K102117 · MUU
Shippert Medical Technologies Corp.
General & Plastic Surgery · 9d
Cleared Aug 05, 2010
MULTI-PURPOSE HEALTH DEVICE
K093322 · BWK
Upc Medical Supplies, Inc. Dba United...
Neurology · 286d
Cleared Aug 05, 2010
I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
K093868 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 231d
Cleared Aug 05, 2010
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
K100382 · JXI
Salumedica, LLC
Neurology · 170d
Cleared Aug 05, 2010
WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM
K100820 · MAX
Wenzel Spine
Orthopedic · 135d
Cleared Aug 05, 2010
MODIFICATION TO SYNTHES MATRIX SYSTEM
K100952 · NKB
Synthes Spine
Orthopedic · 121d