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
69529–69552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2004
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
K040762 · JDS
Synthes (Usa)
Orthopedic · 18d
Cleared Apr 12, 2004
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K040765 · JDW
Synthes (Usa)
Orthopedic · 18d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE
K033362 · LON
Becton, Dickinson & CO
Microbiology · 171d
Cleared Apr 09, 2004
AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY
K033397 · DXN
Avita Corporation
Cardiovascular · 168d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE...
K033907 · LON
Becton, Dickinson & CO
Microbiology · 114d
Cleared Apr 09, 2004
FINE SURGICAL CIRCUMCISION CLAMP
K040052 · HFX
Fine Surgical Instrument Corp.
Obstetrics & Gynecology · 88d
Cleared Apr 09, 2004
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
K040056 · MKJ
Bio-Detek, Inc.
Cardiovascular · 87d
Cleared Apr 09, 2004
PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005
K040256 · MKJ
Bio-Detek, Inc.
Cardiovascular · 65d
Cleared Apr 09, 2004
PARKELL RESIN GLAZE
K040599 · EBD
Parkell, Inc.
Dental · 32d
Cleared Apr 09, 2004
HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT
K040714 · DZE
Innova Corp.
Dental · 22d
Cleared Apr 09, 2004
PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM
K040773 · IYE
Bionix Development Corp.
Radiology · 14d
Cleared Apr 08, 2004
CONVATEC FECAL MANAGEMENT SYSTEM
K032734 · KNT
Convatec, A Bristol-Myers Squibb Co.
Gastroenterology & Urology · 217d
Cleared Apr 08, 2004
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
K033157 · MNW
Tanita Corp. of America
Gastroenterology & Urology · 191d
Cleared Apr 08, 2004
ISOAID ADVANTAGE PD-103, MODEL IAPD-103A
K033770 · KXK
Isoaid, LLC
Radiology · 127d
Cleared Apr 08, 2004
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
K040061 · FRN
Medtronic Minimed
General Hospital · 86d
Cleared Apr 08, 2004
ONEVIEW INTERFACE
K040074 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Apr 08, 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133 · DKZ
Dade Behring, Inc.
Chemistry · 78d
Cleared Apr 08, 2004
MODIFICATION TO GEO STRUCTURE
K040168 · MQP
Interpore Cross Intl.
Orthopedic · 73d
Cleared Apr 08, 2004
EASY MED TN-28 C
K040253 · GZJ
Easy Med Instrument Co., Ltd.
Neurology · 64d
Cleared Apr 08, 2004
BRACHYTHERAPY STRAND DEVICE
K040339 · KXK
Bebig Isotopen-Und Medizintechnik GmbH
Radiology · 57d
Cleared Apr 08, 2004
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
K040644 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Apr 08, 2004
OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL...
K040692 · JIT
Olympus America, Inc.
Chemistry · 22d
Cleared Apr 08, 2004
GEL MARK IV
K040706 · NEU
Senorx, Inc.
General & Plastic Surgery · 21d
Cleared Apr 08, 2004
RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE
K040763 · GEI
Resect Medical, Inc.
General & Plastic Surgery · 14d