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

Filters: Cleared only ×
176,076 results
71905–71928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2003
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K031702 · KWQ
Howmedica Osteonics
Orthopedic · 67d
Cleared Aug 08, 2003
OMNIFIT HFX HIP STEM SERIES
K031744 · JDI
Howmedica Osteonics Corp.
Orthopedic · 64d
Cleared Aug 08, 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K031789 · ODG
Pentax Precision Instrument Corp.
Radiology · 59d
Cleared Aug 08, 2003
HANDMASTER
K031900 · GZI
Ness-Neuromuscular Electrical...
Neurology · 50d
Cleared Aug 08, 2003
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · MQE
Rocket Medical Plc
Radiology · 39d
Cleared Aug 08, 2003
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
K032017 · GGN
Bio-Rad
Hematology · 39d
Cleared Aug 08, 2003
PERIVAC KIT
K032050 · DQX
Boston Scientific Corp
Cardiovascular · 37d
Cleared Aug 08, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K032095 · JDK
Interpore Cross Intl.
Orthopedic · 31d
Cleared Aug 08, 2003
DEPUY ACE VERSANAIL TIBIAL NAIL
K032097 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 31d
Cleared Aug 08, 2003
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
K032117 · DZI
Stryker Instruments
Dental · 30d
Cleared Aug 08, 2003
DATACAPTOR
K032142 · MWI
Capsule Technologie
Cardiovascular · 25d
Cleared Aug 08, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
K032162 · LGD
Beckman Coulter, Inc.
Microbiology · 24d
Cleared Aug 08, 2003
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197 · MAI
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Aug 08, 2003
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
K032206 · FGE
Ev3, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 08, 2003
VKS/TC-PLUS REVISION KNEE
K032215 · JWH
Plus Orthopedics
Orthopedic · 18d
Cleared Aug 08, 2003
BIORCI SCREW
K032224 · HWC
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Aug 08, 2003
GAMMA 3 NAIL SYSTEM
K032244 · HSB
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Aug 08, 2003
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264 · HSD
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Aug 08, 2003
CARDIOVATIONS PORTABLE VIDEO SYSTEM
K032339 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 10d
Cleared Aug 07, 2003
LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001
K023735 · GCJ
Medsys, S.A.
General & Plastic Surgery · 273d
Cleared Aug 07, 2003
AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
K030316 · DRX
Inovise Medical, Inc.
Cardiovascular · 189d
Cleared Aug 07, 2003
SWIFT 2.0, MODEL 132.001
K031158 · JAQ
Nucletron Corp.
Radiology · 118d
Cleared Aug 07, 2003
OTP 1.2
K031349 · MUJ
Nucletron Corp.
Radiology · 100d
Cleared Aug 07, 2003
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
K031432 · FRN
Hk Surgical, Inc.
General Hospital · 93d