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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73705–73728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2002
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
K022781 · LZA
Industrial Clothings, Ltd.
General Hospital · 47d
Cleared Oct 08, 2002
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
K022946 · MMI
Princeton BioMeditech Corp.
Chemistry · 34d
Cleared Oct 08, 2002
LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
K023032 · GFS
Bioresource Technology, Inc.
Chemistry · 27d
Cleared Oct 07, 2002
EXOMIO, MODEL 1.1
K022219 · KPQ
Medcom GmbH
Radiology · 90d
Cleared Oct 07, 2002
TRILUX, Z-TONE, ACRY ROCK
K022299 · ELM
Ruthibras Imp. Exp. Com. DE Materiais...
Dental · 83d
Cleared Oct 07, 2002
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
K022373 · NJH
Cantor & Nissel , Ltd.
Ophthalmic · 77d
Cleared Oct 07, 2002
PULPDENT CALCIUM HYDROXIDE PREPARATION
K022734 · KIF
Pulpdent Corporation
Dental · 52d
Cleared Oct 04, 2002
ACUTEVENTILATOR
K012271 · BTM
Impoex International, Ltd.
Anesthesiology · 442d
Cleared Oct 04, 2002
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
K012344 · NLF
Vanguard Medical Concepts, Inc.
Anesthesiology · 437d
Cleared Oct 04, 2002
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X...
K013525 · MGQ
Coloplast Corp.
General & Plastic Surgery · 346d
Cleared Oct 04, 2002
CANDELA SMOOTHBEAM LASER SYSTEM
K014128 · GEX
Candela Corp.
General & Plastic Surgery · 291d
Cleared Oct 04, 2002
PSA4000 EEG MONITOR WITH FRONTAL PSI
K020671 · OLW
Physiometrix, Inc.
Neurology · 217d
Cleared Oct 04, 2002
PMX COMPACT RESUCITATOR
K021390 · BTM
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 155d
Cleared Oct 04, 2002
NBD CEMENT RESTRICTOR DEVICE
K021788 · JDK
New Business Development, LLC
Orthopedic · 126d
Cleared Oct 04, 2002
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
K022207 · MBI
Axya Medical, Inc.
Orthopedic · 88d
Cleared Oct 04, 2002
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
K022210 · MKJ
Cardiac Science, Inc.
Cardiovascular · 88d
Cleared Oct 04, 2002
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006...
K022257 · DRC
Vomed Volzer Medizintechnik GmbH & Co.
Cardiovascular · 84d
Cleared Oct 04, 2002
KOKOMATE
K022276 · BZG
Ferraris Respiratory, Inc.
Anesthesiology · 81d
Cleared Oct 04, 2002
RHINOSTREAM RHINOMANOMETER MODULE
K022311 · BXQ
Rhino Metrics A/S
Anesthesiology · 79d
Cleared Oct 04, 2002
RHS ACETABULAR COMPONENT
K022382 · LPH
Signal Medical Corp.
Orthopedic · 74d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · HWC
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Oct 04, 2002
NUGEN FX SCREW
K023022 · HWC
Bionx Implants, Inc.
Orthopedic · 23d
Cleared Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
K023049 · JGS
Beckman Coulter, Inc.
Chemistry · 22d
Cleared Oct 04, 2002
CLASSIC GREAT TOE IMPLANT
K023086 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 17d