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
35953–35976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2014
EEVA SYSTEM
K142147 · PBH
Auxogyn, Inc.
Obstetrics & Gynecology · 111d
Cleared Nov 24, 2014
MAYFIELD Skull Clamp
K142238 · HBL
Integra LifeSciences Corporation
Neurology · 103d
Cleared Nov 24, 2014
KangLi pedical screw spinal system
K142290 · MNH
Suzhou Kangli Orthopaedics Instrument...
Orthopedic · 98d
Cleared Nov 24, 2014
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical...
K142403 · KWS
Zimmer GmbH
Orthopedic · 89d
Cleared Nov 24, 2014
IntelAir Nasal Airway Support System
K142467 · CCK
Abeon Medical Corporation
Anesthesiology · 82d
Cleared Nov 24, 2014
Collagen Dental Membrane - Conformable IIBP
K142496 · NPL
Collagen Matrix, Inc.
Dental · 80d
Cleared Nov 24, 2014
Atlas SPEEDER Head/Neck
K142802 · MOS
Quality Electrodynamics, LLC
Radiology · 56d
Cleared Nov 22, 2014
XPERT FLU/RSV XC ASSAY
K142045 · OCC
Cepheid
Microbiology · 117d
Cleared Nov 21, 2014
STIM PROBE
K133348 · ETN
Spes Medica Srl
Ear, Nose, Throat · 387d
Cleared Nov 21, 2014
SGS DENTAL IMPLANT
K133362 · DZE
Sgs International, Ltd.
Dental · 385d
Cleared Nov 21, 2014
PHILIPS IQON SPECTRAL CT
K133674 · JAK
Philips Healthcare (Cleveland)
Radiology · 357d
Cleared Nov 21, 2014
LG SMARTHEALTH
K133997 · DRG
Lg Electronics
Cardiovascular · 329d
Cleared Nov 21, 2014
DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE
K134006 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 329d
Cleared Nov 21, 2014
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
K141377 · LZO
Merete Medical GmbH
Orthopedic · 178d
Cleared Nov 21, 2014
SUDOSCAN
K141872 · GZO
Impeto Medical, Inc.
Neurology · 133d
Cleared Nov 21, 2014
GLIDESHEATH SLENDER
K142183 · DYB
Terumo Medical Corporation
Cardiovascular · 105d
Cleared Nov 21, 2014
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
K142197 · IYN
Konica Minolta, Inc.
Radiology · 102d
Cleared Nov 21, 2014
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT...
K142434 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 21, 2014
PK Lap Loop
K142525 · HIN
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 74d
Cleared Nov 21, 2014
Lesion-Loc Iodine I-125 Seed/Needle
K142668 · KXK
Intramedical Imaging, LLC
Radiology · 63d
Cleared Nov 21, 2014
ZEUS (ZIO ECG Utilization Service) System
K142681 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 63d
Cleared Nov 21, 2014
5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L...
K142868 · GEI
Purple Surgical International Limited
General & Plastic Surgery · 51d
Cleared Nov 21, 2014
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
K143026 · JJX
Aalto Scientific, Ltd.
Chemistry · 31d
Cleared Nov 21, 2014
VEGA Knee System
K143106 · JWH
Aesculap Implant Systems, LLC
Orthopedic · 23d