FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68785–68808 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2004
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K033941 · HQF
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Feb 09, 2004
MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
K031741 · CCK
Alaris Medical Systems, Inc.
Anesthesiology · 250d
Cleared Feb 09, 2004
CSTAT, MODELS 09-0014-01 AND 09-0014-02
K032125 · DXC
Vascular Control Systems, Inc.
Radiology · 214d
Cleared Feb 09, 2004
ONE.CLICK NEEDLE
K033575 · FMI
B.Braun Medical, Inc.
General Hospital · 89d
Cleared Feb 09, 2004
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K033674 · LCP
Seradyn, Inc.
Chemistry · 77d
Cleared Feb 09, 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713 · DIO
Dade Behring, Inc.
Toxicology · 75d
Cleared Feb 09, 2004
APOGEE ELITE
K034030 · GEX
Cynosure, Inc.
General & Plastic Surgery · 42d
Cleared Feb 06, 2004
TEETH IN AN HOUR - ARK IMPLANT CONCEPT
K030685 · DZE
Nobel Biocare AB
Dental · 338d
Cleared Feb 06, 2004
BAWMED E-Z BAG RESUSCITATOR
K031434 · BTM
Bawmed UK
Anesthesiology · 276d
Cleared Feb 06, 2004
PROCEARA COPINGS AND PONTIC
K032562 · ELL
Nobel Biocare AB
Dental · 170d
Cleared Feb 06, 2004
CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS
K033213 · EFB
Codent Technical Industry Co., Ltd.
Dental · 126d
Cleared Feb 06, 2004
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703 · DYH
Dentsply Intl.
Dental · 73d
Cleared Feb 06, 2004
VOLAR RADIUS PLATE WITH ANGULAR STABILITY
K033756 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 67d
Cleared Feb 06, 2004
RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · LRK
Respironics, Inc.
Dental · 58d
Cleared Feb 06, 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · LRK
Respironics, Inc.
Dental · 58d
Cleared Feb 06, 2004
HERMES BOND
K033974 · KLE
3M Espe AG Dental Products
Dental · 46d
Cleared Feb 06, 2004
SEDLINE WITH FRONTAL PSI
K033999 · OLW
Physiometrix, Inc.
Neurology · 44d
Cleared Feb 06, 2004
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR...
K034060 · LYZ
Hong Huang Tang Industrial Co., Ltd.
General Hospital · 37d
Cleared Feb 06, 2004
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
K040142 · LLZ
Adac Laboratories
Radiology · 15d
Cleared Feb 05, 2004
40 L HIGH FLOW INSUFFLATOR F108
K030837 · HIF
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 325d
Cleared Feb 05, 2004
TRIMED RADIAL BULLET
K030877 · HRS
Tri-Med, Inc.
Orthopedic · 322d
Cleared Feb 05, 2004
QCA (VERSION 3.1)
K031363 · NQN
Cell Analysis, Inc.
Pathology · 281d
Cleared Feb 05, 2004
MOSSMED DUAL INTERMITTENT ASPIRATOR
K031492 · KNT
Moss Medical Products
Gastroenterology & Urology · 269d
Cleared Feb 05, 2004
VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN
K032416 · EIH
Shofu Dental Corp.
Dental · 184d