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
78577–78600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2001
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE...
K011370 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER...
K011371 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT...
K011377 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 06, 2001
PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
K001917 · MJN
Arteria Medical Science, Inc.
Cardiovascular · 348d
Cleared Jun 06, 2001
FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
K002410 · IPF
Dysphagia, LLC
Physical Medicine · 303d
Cleared Jun 06, 2001
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
K002846 · BTM
Headstar Medical Products Co., Ltd.
Anesthesiology · 267d
Cleared Jun 06, 2001
CLARREN HELMET
K003035 · MVA
Children'S Hospital & Medical Center
Neurology · 251d
Cleared Jun 06, 2001
BACTEC MGIT 960 SIR KITS
K003062 · MJA
Bd Becton Dickinson Vacutainer...
Microbiology · 247d
Cleared Jun 06, 2001
OTRES TOOTHBRUSH SANITIZER MODEL TB100W
K003517 · MCF
Otres, LLC
Dental · 204d
Cleared Jun 06, 2001
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
K003570 · MCW
Bacchus Vascular, Inc.
Cardiovascular · 198d
Cleared Jun 06, 2001
SMITH & NEPHEW RESTIM
K003596 · IPF
Smith & Nephew, Inc.
Physical Medicine · 197d
Cleared Jun 06, 2001
CPR EZY MASK AND PAD
K003937 · LIX
Medteq Innovations Pty, Ltd.
Cardiovascular · 168d
Cleared Jun 06, 2001
STIMUPLEX HNS-11
K003983 · BXN
Stockert GmbH
Anesthesiology · 162d
Cleared Jun 06, 2001
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
K010083 · DTK
Cordis Corp.
Cardiovascular · 146d
Cleared Jun 06, 2001
USS-LINE EXTENSION
K010108 · MNI
Synthes
Orthopedic · 145d
Cleared Jun 06, 2001
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
K010193 · KFF
International Technidyne Corp.
Hematology · 135d
Cleared Jun 06, 2001
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
K010471 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 106d
Cleared Jun 06, 2001
SPARROWHAWK DISPOSABLE
K010473 · DWZ
Atc Technologies, Inc.
Cardiovascular · 106d
Cleared Jun 06, 2001
TBW
K010545 · NDL
Tri-Med, Inc.
Orthopedic · 103d
Cleared Jun 06, 2001
UNIQUE AMBULATORY EEG
K010697 · GWQ
Axon Systems, Inc.
Neurology · 90d
Cleared Jun 06, 2001
STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN...
K010856 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 76d
Cleared Jun 06, 2001
TEMP-A-SURE
K010866 · FLL
Homecare Technologies , Ltd.
General Hospital · 76d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010903 · MNI
Endius, Inc.
Orthopedic · 72d