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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74209–74232 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2002
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES...
K021955 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 116d
Cleared Oct 08, 2002
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II,...
K022226 · GEX
Altus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Oct 08, 2002
FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
K022228 · GEX
Iridex Corp
General & Plastic Surgery · 90d
Cleared Oct 08, 2002
KONRAD, MODEL V.2.0
K022307 · MUJ
Mrc Systems GmbH
Radiology · 84d
Cleared Oct 08, 2002
INNOVA AND INNOVA 2000 S
K022322 · OWB
Ge Medical Systems, Inc.
Radiology · 83d
Cleared Oct 08, 2002
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441 · JOJ
Advanced Sterilization Products
General Hospital · 75d
Cleared Oct 08, 2002
GETTIG DISPOSABLE SYRINGES
K022495 · FMF
Gettig Pharmaceutical Instrument Co.
General Hospital · 71d
Cleared Oct 08, 2002
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K022565 · JAA
Stereotaxis, Inc.
Radiology · 67d
Cleared Oct 08, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022656 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 60d
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