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
51505–51528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2009
SMART TENS, MODEL: D-BC05T
K091045 · GZJ
Body Clock Health Care, Ltd.
Neurology · 249d
Cleared Dec 18, 2009
ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE
K092044 · ILX
Orthocor Medical
Physical Medicine · 165d
Cleared Dec 18, 2009
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
K092483 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 127d
Cleared Dec 18, 2009
DYNAREX STERILE LUBRICATING JELLY
K092488 · KMJ
Dynarex Corporation
General Hospital · 127d
Cleared Dec 18, 2009
GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM,...
K092546 · GXY
Gmdasz Manufacturing Co., Ltd.
Neurology · 121d
Cleared Dec 18, 2009
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
K092648 · CBK
Respironics Inc., Sleep & Home...
Anesthesiology · 112d
Cleared Dec 18, 2009
PERIOPHIL BIPHASIC
K092788 · LYC
Cytophil, Inc.
Dental · 99d
Cleared Dec 18, 2009
AMSCO WARMING CABINET
K092823 · LGZ
STERIS Corporation
General Hospital · 95d
Cleared Dec 18, 2009
LED LAMP OR OTHER
K092883 · HJO
Intravista Medical Systems, Inc.
Ophthalmic · 91d
Cleared Dec 18, 2009
FLUID-FILLED TEETHER
K092910 · KKO
Qualiman Industrial Co., Ltd.
Dental · 87d
Cleared Dec 18, 2009
STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC...
K093001 · JPA
Diagnostica Stago, Incorporated
Hematology · 81d
Cleared Dec 18, 2009
ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
K093050 · DQY
Arrow Intl., Inc.
Cardiovascular · 79d
Cleared Dec 18, 2009
ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT
K093113 · NHA
Institut Straumann AG
Dental · 78d
Cleared Dec 18, 2009
INTELLIBRIDGE SYSTEM
K093177 · MWI
Philips Medical Systems
Cardiovascular · 71d
Cleared Dec 18, 2009
SMARTWAND-DTX
K093557 · LWH
Clearcount Medical Solutions
General & Plastic Surgery · 32d
Cleared Dec 18, 2009
AF 840 PH.I.S.I.O. ARTERIAL FILTER
K093601 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Dec 18, 2009
RESTORATION ADM SYSTEM X3 ACETABULAR
K093644 · MEH
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Dec 17, 2009
HEALTHEPOD
K083174 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 416d
Cleared Dec 17, 2009
ATLANTIS HYPERBARIC CHAMBER VENTILATOR
K092264 · CBK
Providence Global Medical, Inc.
Anesthesiology · 142d
Cleared Dec 17, 2009
LAC-MAC INNERBLOC LR SURGICAL GOWNS
K092344 · FYA
Lac Mac, Ltd.
General Hospital · 135d
Cleared Dec 17, 2009
DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES
K092557 · FLL
Harvard Medical Devices , Ltd.
General Hospital · 119d
Cleared Dec 17, 2009
Xpert VanA Assay
K092953 · NIJ
Cepheid
Microbiology · 84d
Cleared Dec 17, 2009
GALILEOS IMPLANT, VERSION 1.7
K093090 · LLZ
Sicat GmbH & Co. KG
Radiology · 77d
Cleared Dec 17, 2009
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER
K093252 · LJS
Footprint Medical, Inc.
General Hospital · 62d