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
52225–52248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2009
PACSCAN PLUS, MODELS 300P AND 300AP
K092637 · ITX
Sonomed, Inc.
Radiology · 28d
Cleared Sep 23, 2009
BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2
K090339 · FLE
Belimed Sauter AG
General Hospital · 225d
Cleared Sep 23, 2009
ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
K090989 · MKJ
Zoll Medical Corp
Cardiovascular · 169d
Cleared Sep 23, 2009
VESOCCLUDE LIGATING CLIP
K091060 · FZP
Vesocclude Medical, LLC
General & Plastic Surgery · 162d
Cleared Sep 23, 2009
LIPOEZE LASER ASSISTED ASPIRATION CANNULA
K091800 · GEX
Curve Medical
General & Plastic Surgery · 98d
Cleared Sep 23, 2009
LAURIMED SPINAL INJECTION SYSTEM
K091818 · BSP
Laurimed, LLC
Anesthesiology · 97d
Cleared Sep 23, 2009
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB
K091930 · GCJ
Anchor Products Co.
General & Plastic Surgery · 85d
Cleared Sep 23, 2009
MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
K091972 · DQD
Stethoscope Technologies, Inc.
Cardiovascular · 84d
Cleared Sep 23, 2009
APTUS K-WIRE SYSTEM
K092038 · HTY
Medartis AG
Orthopedic · 79d
Cleared Sep 23, 2009
VARIAX ELBOW SYSTEM LINE EXTENSION
K092671 · HRS
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Sep 23, 2009
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING...
K092680 · MHX
GE Healthcare Finland Oy
Cardiovascular · 22d
Cleared Sep 22, 2009
ASTRA TECH IMPLANT SYSTEM
K091239 · DZE
Astra Tech AB
Dental · 148d
Cleared Sep 22, 2009
MRI NEURO DRAPE
K091343 · KKX
Surgivision, Inc.
General Hospital · 139d
Cleared Sep 22, 2009
DISPOSABLE SPO2 SENSOR M1134A
K091572 · DQA
Philips Medizinsysteme Boeblingen...
Anesthesiology · 112d
Cleared Sep 22, 2009
NOBELPROCERA TI ABUTMENT
K091756 · NHA
Nobel Biocare AB
Dental · 98d
Cleared Sep 22, 2009
ACL TOP 700 LAS
K091980 · GKP
Instrumentation Laboratory CO
Hematology · 83d
Cleared Sep 22, 2009
EXTEND FRAME SYSTEM, MODEL 1009633
K092083 · IWB
Elekta Instrument AB
Radiology · 75d
Cleared Sep 22, 2009
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
K092143 · MEH
Aesculap Implant Systems, Inc.
Orthopedic · 69d
Cleared Sep 22, 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315
K092495 · MJN
Ev3 Neurovascular
Cardiovascular · 39d
Cleared Sep 22, 2009
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K092742 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 14d
Cleared Sep 21, 2009
BELLUS SHADING KIT
K090718 · EIH
3M Espe AG Dental Products
Dental · 187d
Cleared Sep 21, 2009
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054
K090752 · NRY
Penumbra, Inc.
Neurology · 185d
Cleared Sep 21, 2009
PERSONAL WHEEZOMETER
K090863 · BZM
Karmelsonix
Anesthesiology · 175d
Cleared Sep 21, 2009
HEALTHANYWHERE SYSTEM
K091220 · DRG
Healthanywhere, an Igeacare System...
Cardiovascular · 147d