FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68185–68208 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 07, 2004
PHOENIX INFUSION CATHETER
K033017 · JXG
Phoenix Biomedical
Neurology · 194d
Cleared Apr 07, 2004
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST...
K033866 · DIO
Lin-Zhi International, Inc.
Toxicology · 117d
Cleared Apr 07, 2004
BIOFREE
K033925 · EIA
Dental Components, Inc.
Dental · 111d
Cleared Apr 07, 2004
POLYLASE LP
K040055 · GEX
Ddc Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Apr 07, 2004
LIFESTYLE CIRCULATORY ENHANCER
K040084 · BWF
Advanced Circulatory Systems, Inc.
Anesthesiology · 83d
Cleared Apr 07, 2004
YUE PFONG SAFETY SYRINGE (3ML)
K040105 · MEG
Yue Pfong International Industrial...
General Hospital · 78d
Cleared Apr 07, 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · KPS
GE Medical Systems
Radiology · 72d
Cleared Apr 07, 2004
CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM
K040195 · LLZ
Witt Biomedical Corp
Radiology · 70d