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

Filters: Cleared only ×
175,820 results
38689–38712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2014
CAMBER SPINE DIAGON OBLIQUE CAGE
K134038 · MAX
Camber Spine
Orthopedic · 79d
Cleared Mar 20, 2014
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX...
K140253 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Mar 20, 2014
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
K140465 · NQN
Ventana Medical Systems, Inc.
Pathology · 24d
Cleared Mar 19, 2014
METALLIC INTRAMEDULLARY NAIL SYSTEM
K132078 · HSB
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 257d
Cleared Mar 19, 2014
SRS ENDOSCOPIC STAPLING SYSTEM
K132151 · ODE
Medigus , Ltd.
Gastroenterology & Urology · 251d
Cleared Mar 19, 2014
MELYS ATRIAL FIBRILLATION SCREENING MONITOR
K132206 · DXH
Advanced Fluidics, LLC
Cardiovascular · 246d
Cleared Mar 19, 2014
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
K133144 · PGK
Crossbay Medical, Inc.
Obstetrics & Gynecology · 153d
Cleared Mar 19, 2014
CIRRUS PHOTO
K133217 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 152d
Cleared Mar 19, 2014
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
K133374 · KWP
Pioneer Surgical Technology, Inc....
Orthopedic · 138d
Cleared Mar 19, 2014
SEAL SINGLE-USE BIOPSY VALVE
K133734 · OCX
Endochoice, Inc.
Gastroenterology & Urology · 100d
Cleared Mar 19, 2014
SPEED XL
K133780 · JDR
Biomedical Ent., Inc.
Orthopedic · 97d
Cleared Mar 19, 2014
IVUE 500
K133892 · HLI
Optovue, Inc.
Ophthalmic · 89d
Cleared Mar 19, 2014
EMBOL-X INTRODUCER SHEATH
K140398 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Mar 18, 2014
ELECTRONIC THERMOMETER
K131210 · FLL
Shenzhen Pump Medical System Co., Ltd.
General Hospital · 323d
Cleared Mar 18, 2014
SPHINX JR
K132975 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 176d
Cleared Mar 18, 2014
TINNITUS SOUNDSUPPORT
K133308 · KLW
Oticon A/S
Ear, Nose, Throat · 141d
Cleared Mar 18, 2014
ASAHI GAIA FIRST, SECOND, THIRD
K133865 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 89d
Cleared Mar 18, 2014
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
K133894 · FPA
Terumo Europe N.V.
General Hospital · 88d
Cleared Mar 18, 2014
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA...
K140105 · OPX
The Binding Site
Immunology · 62d
Cleared Mar 17, 2014
SATURN DENTAL IMPLANT
K131258 · DZE
Cortex Dental Implants Industries , Ltd.
Dental · 319d
Cleared Mar 17, 2014
FORESEE (4C) IMAGING SYSTEM
K133209 · NQQ
Diagnostic Photonics, Inc.
General & Plastic Surgery · 151d
Cleared Mar 17, 2014
BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH...
K134054 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 76d
Cleared Mar 14, 2014
EZ-OX PLUS GENERATION II
K131386 · ECX
Air Liquide Healthcare America
Anesthesiology · 304d
Cleared Mar 14, 2014
MANUKA FILL WOUND DRESSING
K131796 · FRO
Links Medical Products, Inc.
General & Plastic Surgery · 269d