FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38905–38928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2013
ARTHREX IBALANCE TKA SYSTEM
K133342 · JWH
Arthrex, Inc.
Orthopedic · 48d
Cleared Dec 16, 2013
HYALMIX CREAM
K123678 · FRO
Igi Laboratories, Inc.
General & Plastic Surgery · 381d
Cleared Dec 16, 2013
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS,...
K130073 · MNI
Mikron Makina Sanayi VE Ticaret Ltd....
Orthopedic · 339d
Cleared Dec 16, 2013
CLEARGUARD HD END CAP
K131060 · PEH
Pursuit Vascular, Inc.
Gastroenterology & Urology · 244d
Cleared Dec 16, 2013
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
K131792 · GXQ
Synthes, Inc.
Neurology · 181d
Cleared Dec 16, 2013
CORIN METAFIX HIP STEM
K131952 · LZO
Corin USA
Orthopedic · 172d
Cleared Dec 16, 2013
CORIN MINIHIP STEM
K131986 · LZO
Corin USA
Orthopedic · 171d
Cleared Dec 16, 2013
2D PERFUSION
K132147 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 158d
Cleared Dec 16, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES
K132240 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 151d
Cleared Dec 16, 2013
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · DSA
Boston Scientific
Cardiovascular · 150d
Cleared Dec 16, 2013
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
K132522 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 126d
Cleared Dec 16, 2013
ONETOUCH REVEAL
K132618 · MRZ
Lifescan, Inc.
General Hospital · 117d
Cleared Dec 16, 2013
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL,...
K132688 · DIF
Biochemical Diagnostics, Inc.
Toxicology · 110d
Cleared Dec 16, 2013
STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
K132785 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 101d
Cleared Dec 16, 2013
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
K132910 · HWC
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Dec 16, 2013
FUSIONSYNC, CHIMAERA FUSIONSYNC
K132963 · LLZ
Chimaera GmbH
Radiology · 87d
Cleared Dec 16, 2013
RHYTHM VIEW WORKSTATION
K133305 · DQK
Topera, Inc.
Cardiovascular · 49d
Cleared Dec 16, 2013
SONOSITE EDGE ULTRASOUND SYSTEM
K133454 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Dec 13, 2013
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET...
K121248 · JXG
Moller Medical GmbH
Neurology · 597d
Cleared Dec 13, 2013
HEPAFAT SCAN
K122035 · LNH
Resonance Health Analysis Services...
Radiology · 520d
Cleared Dec 13, 2013
MICRODOSE SI
K130704 · MUE
Philips Digital Mammography Sweden AB
Radiology · 273d
Cleared Dec 13, 2013
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
K130738 · GDW
Nanjing Maidixin Medical Device Co.,...
General & Plastic Surgery · 270d
Cleared Dec 13, 2013
GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
K130913 · MAX
Genesys Spine
Orthopedic · 255d
Cleared Dec 13, 2013
PROVANT THERAPY SYSTEM
K131979 · ILX
Regenesis Biomedical, Inc.
Physical Medicine · 168d