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
39721–39744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2013
POWER FREE VINYL EXAMINATION GLOVES
K122102 · LYZ
Wang Tong Xinghua Co., Ltd.
General Hospital · 420d
Cleared Sep 09, 2013
FRESENIUS LIBERTY CYCLER
K123630 · FKX
Fresenius Medical Care North America,...
Gastroenterology & Urology · 290d
Cleared Sep 09, 2013
RESPIRE PINK SERIES - HERBST
K131138 · LRK
Respire Medical
Dental · 139d
Cleared Sep 09, 2013
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
K132073 · DQK
St Jude Medical
Cardiovascular · 68d
Cleared Sep 09, 2013
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
K132216 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 54d
Cleared Sep 09, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K132465 · PSZ
Princeton BioMeditech Corp.
Microbiology · 33d
Cleared Sep 06, 2013
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033 · NOT
Ventana Medical Systems, Inc.
Pathology · 519d
Cleared Sep 06, 2013
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
K121844 · LYY
Worldmed Manufacturing Sdn. Bhd.
General Hospital · 438d
Cleared Sep 06, 2013
RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
K122235 · JOH
Teleflexmedical, Inc.
Anesthesiology · 407d
Cleared Sep 06, 2013
PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K130010 · NYI
Nanostring Technologies
Pathology · 246d
Cleared Sep 06, 2013
STRAWBERRY, STRAWBERRY & CREAM
K130341 · OLI
Laser Lipo Limited
General & Plastic Surgery · 207d
Cleared Sep 06, 2013
FREEMIE BREAST COLLECTION SYSTEM
K130349 · HGX
Dao Health
Obstetrics & Gynecology · 206d
Cleared Sep 06, 2013
ALIVECOR HEART MONITOR
K130409 · DPS
AliveCor, Inc.
Cardiovascular · 199d
Cleared Sep 06, 2013
XPERCT REL. 3
K130893 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 158d
Cleared Sep 06, 2013
LIAISON XL HCG
K131037 · DHA
DiaSorin, Inc.
Chemistry · 144d
Cleared Sep 06, 2013
PEAK Z
K131357 · KLE
Ultradent Products, Inc.
Dental · 119d
Cleared Sep 06, 2013
JUSHA-C31 MEDICAL DISPLAY
K131389 · LLZ
Nanjing Jusha Display Technology Co.,...
Radiology · 115d
Cleared Sep 06, 2013
FIRECR DENTALIMAGING SYSTEM
K131442 · MUH
3Disc Americas
Radiology · 109d
Cleared Sep 06, 2013
GORE SEAMGUARD REINFORCEMENT
K131658 · OXC
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 92d
Cleared Sep 06, 2013
EYESEECAM VHIT
K131681 · GWN
Interacoustics A/S
Neurology · 88d
Cleared Sep 06, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
K131813 · OCC
Quidel Corp.
Microbiology · 78d
Cleared Sep 06, 2013
SINGLE USE GROUNDING PAD
K132136 · GEI
Lccs Products Limited
General & Plastic Surgery · 57d
Cleared Sep 06, 2013
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
K132233 · FMI
Terumo Europe N.V.
General Hospital · 50d
Cleared Sep 06, 2013
COMPREHENSIVE REVERSE SHOULDER SCREWS
K132239 · PHX
Biomet Manufacturing Corp
Orthopedic · 50d