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
43417–43440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2012
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
K122066 · JZG
The Binding Site Group , Ltd.
Immunology · 45d
Cleared Aug 30, 2012
PROTURA COUCH SOFTWARE
K122201 · JAI
Med-Tec, Inc. D/B/A Civco Medical...
Radiology · 36d
Cleared Aug 30, 2012
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K122353 · GXN
Aesculap, Inc.
Neurology · 27d
Cleared Aug 30, 2012
RUBICON 18 SUPPORT CATHETER
K122394 · DQY
Boston Scientific Corp
Cardiovascular · 23d
Cleared Aug 30, 2012
CERVICAL CAGE
K122444 · ODP
Eisertech, LLC
Orthopedic · 20d
Cleared Aug 29, 2012
IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE
K121230 · EBF
Ivoclar Vivadent, AG
Dental · 127d
Cleared Aug 29, 2012
NEURO VENTION LAMINPLASTY PLATING SYSTEM
K121276 · NQW
Neurovention, LLC
Orthopedic · 124d
Cleared Aug 29, 2012
SINUS DILATION SYSTEM
K121351 · LRC
Entrigue Surgical, Inc.
Ear, Nose, Throat · 117d
Cleared Aug 29, 2012
INFILL GRAFT DELIVERY SYSTEM
K121476 · FMF
Pinnacle Spine Group, LLC
General Hospital · 103d
Cleared Aug 29, 2012
CAPSTONE SPINAL SYSTEM
K121760 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 75d
Cleared Aug 29, 2012
STAXX XD SYSTEM
K121889 · MQP
Spine Wave, Inc.
Orthopedic · 62d
Cleared Aug 29, 2012
HEM-7200-Z (BP742)
K121932 · DXN
Omron Healthcare, Inc.
Cardiovascular · 58d
Cleared Aug 29, 2012
TOMOTHERAPY TREATMENT SYSTEM
K121934 · IYE
Accuray Incorporated
Radiology · 58d
Cleared Aug 29, 2012
INTRODUCER SET, MODEL ADELANTE-S SERIES
K122084 · DYB
Oscor, Inc.
Cardiovascular · 44d
Cleared Aug 29, 2012
ARTISAN EXTEND CONTROL CATHETER
K122275 · DRA
Hansen Medical
Cardiovascular · 30d
Cleared Aug 29, 2012
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K122276 · FZP
AtriCure, Inc.
General & Plastic Surgery · 30d
Cleared Aug 29, 2012
PADNET 2.0
K122281 · JOM
Biomedix, Inc.
Cardiovascular · 30d
Cleared Aug 29, 2012
AZUR DETACHABLE 35
K122316 · KRD
MicroVention, Inc.
Cardiovascular · 28d
Cleared Aug 29, 2012
TETRIS II
K122317 · MAX
Signus Medizintechnik GmbH
Orthopedic · 28d
Cleared Aug 29, 2012
INTELLIVUE PATIENT MONITOR
K122439 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 19d
Cleared Aug 28, 2012
AIXPLORER
K112255 · IYN
Supersonic Imagine
Radiology · 389d
Cleared Aug 28, 2012
PMMA CAD/CAM DISC
K112967 · EBG
Polident D.O.O., Dental Products...
Dental · 328d
Cleared Aug 28, 2012
XIA 3 SPINAL SYSTEM
K113666 · NKB
Stryker Spine
Orthopedic · 259d
Cleared Aug 28, 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY...
K120246 · MUE
Carestream Health, Inc.
Radiology · 214d