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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
63961–63984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2005
STRYKER COMPARTMENTAL KNEE SYSTEM
K052917 · NPJ
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Dec 27, 2005
21.3INCH MONOCHROME LCD MONITOR
K052942 · LLZ
Nec-Mitsubishi Electric Visual...
Radiology · 68d
Cleared Dec 27, 2005
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 62d
Cleared Dec 27, 2005
IST PEDICLE SCREW SYSTEM
K053276 · NKB
Innovative Spinal Technologies, Inc.
Orthopedic · 34d
Cleared Dec 27, 2005
MENTOR NOVASILK MESH
K053414 · OTP
Mentor Corp.
Obstetrics & Gynecology · 20d
Cleared Dec 27, 2005
ARTHROCARE PERC-D SPINEWAND
K053447 · GEI
Arthrocare Corp.
General & Plastic Surgery · 18d
Cleared Dec 27, 2005
SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
K053482 · GAW
Sutura, Inc.
General & Plastic Surgery · 13d
Cleared Dec 23, 2005
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
K050944 · DBF
Kamiya Biomedical Co.
Immunology · 253d
Cleared Dec 23, 2005
COAG-A-MATE MTX III
K051030 · JPA
bioMerieux, Inc.
Hematology · 245d
Cleared Dec 23, 2005
INSULIN PUMP
K051041 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 242d
Cleared Dec 23, 2005
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH...
K051472 · GGN
Hyphen Biomed
Hematology · 203d
Cleared Dec 23, 2005
HEART STG SYSTEM AND SOFTWARE
K052283 · DQD
Stethographics, Inc.
Cardiovascular · 123d
Cleared Dec 23, 2005
HDC SPIDER SCREW
K052471 · DZE
Hdc S.R.L.
Dental · 106d
Cleared Dec 23, 2005
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
K052562 · EWO
Interacoustics AS
Ear, Nose, Throat · 95d
Cleared Dec 23, 2005
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
K052669 · DQA
Nonin Medical, Inc.
Anesthesiology · 87d
Cleared Dec 23, 2005
VENTLINK SYSTEM
K052751 · MOD
Mediserve Information Systems, Inc.
Anesthesiology · 84d
Cleared Dec 23, 2005
SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
K052790 · LHI
Cardinal Health, Alaris Products
General Hospital · 81d
Cleared Dec 23, 2005
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE...
K052819 · DEM
Ortho-Clinical Diagnostics, Inc.
Immunology · 80d
Cleared Dec 23, 2005
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
K052826 · LBZ
Seradyn, Inc.
Toxicology · 79d
Cleared Dec 23, 2005
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
K052867 · JMO
Ortho-Clinical Diagnostics, Inc.
Chemistry · 73d
Cleared Dec 23, 2005
ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314
K052885 · NHA
Nobel Biocare USA, LLC
Dental · 71d
Cleared Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
K053104 · JIS
Dade Behring, Inc.
Chemistry · 49d
Cleared Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
K053109 · NQD
Dade Behring, Inc.
Chemistry · 49d
Cleared Dec 23, 2005
AMBU MARK IV RESUSCITATOR
K053140 · BTM
Ambu A/S
Anesthesiology · 44d